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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
MILDT
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01207674
First received: September 22, 2010
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Pathological or "at Risk" Gambling
 Other: Summons of patients and filling questionnaire

Study Type: Interventional
Official Title: Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

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).


Enrollment: 622
Study Start Date: April 2009
Estimated Study Completion Date: September 2016
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01207674     History of Changes
Other Study ID Numbers: 08/9-F
Study First Received: September 22, 2010
Last Updated: February 7, 2013
Health Authority: France : AFSSAPS

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
Impulse Control Disorders
Mental Disorders
Salicylic Acid
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013