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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01207674
Other study ID # BRD/08/09-F
Secondary ID
Status Completed
Phase N/A
First received September 22, 2010
Last updated February 14, 2018
Start date April 2009
Est. completion date September 2016

Study information

Verified date February 2018
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 641
Est. completion date September 2016
Est. primary completion date November 2011
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
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

Sponsors (2)

Lead Sponsor Collaborator
Nantes University Hospital MILDT

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 5 years
Secondary Socio-demographic data gender, age, marital status, educational level, professional status, professional category, and level of income per month. 5 years
Secondary 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). 5 years