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

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ClinicalTrials.gov Identifier: NCT01207674
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
MILDT
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment
Pathological or "at Risk" Gambling Other: Summons of patients and filling questionnaire

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 641 participants
Allocation: Non-Randomized
Primary Purpose: Other
Official Title: Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers.
Study Start Date : April 2009
Primary Completion Date : November 2011
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Other: Summons of patients and filling questionnaire
    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 Measures :
  1. 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).


Secondary Outcome Measures :
  1. Socio-demographic data [ Time Frame: 5 years ]
    gender, age, marital status, educational level, professional status, professional category, and level of income per month.

  2. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207674


Locations
France
Bordeaux University Hospital
Bordeaux, France
Clermont Ferrand university Hospital
Clermont Ferrand, France
Louis Mourier hospital
Colombes, France
Marseille University Hospital
Marseille, France
Nantes University Hospital
Nantes, France
Marmottan hospital
Paris, France
Paul Brousse hospital
Villejuif, France
Sponsors and Collaborators
Nantes University Hospital
MILDT
Investigators
Study Director: Marie GRALL BRONNEC, MD Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01207674     History of Changes
Other Study ID Numbers: BRD/08/09-F
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Keywords provided by Nantes University Hospital:
Pathological gambling
"at risk" gambling
gambling practice evolution
psychiatric comorbidities
gambling trajectory
cognitive distortions
ADHD
addiction
recourse to care

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders