Pathological or "at Risk" GamblingNCT01207674
Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers (JEU)
A study testing Summons of patients and filling questionnaire in people with Pathological or "at Risk" Gambling, run by Nantes University Hospital at 7 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pathological or "at Risk" Gambling
- What is being tested?
- Summons of patients and filling questionnaire
- How many people
- 641 participants
- Where
- 7 sitesFrance
- Study dates
- Apr 2009to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- To be 18 to 65 years old
- To have gambled during the last year
- To gamble at least one time a year
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Bordeaux University Hospital
Bordeaux
Clermont Ferrand university Hospital
Clermont-Ferrand
Louis Mourier hospital
Colombes
Marseille University Hospital
Marseille
Nantes University Hospital
Nantes
Marmottan hospital
Paris
Paul Brousse hospital
Villejuif
About this study
Official title: 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.
- Conditions
- Pathological or "at Risk" Gambling
- Being tested
- Summons of patients and filling questionnaire
- Keywords
- Pathological gambling, "at risk" gambling, gambling practice evolution, psychiatric comorbidities, gambling trajectory, cognitive distortions, ADHD, addiction, recourse to care
- Medical subject headings
- Gambling, Attention Deficit Disorder with Hyperactivity, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summons of patients and filling questionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 years
Secondary outcomes (2)
Socio-demographic data
gender, age, marital status, educational level, professional status, professional category, and level of income per month.
Measured: 5 years
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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startApr 2009
- Primary completionNov 2011
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pathological or "at Risk" GamblingStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MILDT
- Responsible party
- Sponsor
- Investigators
- Marie GRALL BRONNEC, MD, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207674
- Sponsor's protocol ID
- BRD/08/09-F
- Status last verified
- Feb 2018
- First submitted
- 22 Sep 2010
- Last updated
- 15 Feb 2018
- Results posted
- No
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.
PubMed 32075821Challet-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.
PubMed 25141820
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers.
- ClinicalTrials.gov ID
- NCT01207674
- Acronym / sponsor ID
- BRD/08/09-F
- Conditions
- Pathological or "at Risk" Gambling
- Keywords
- Pathological gambling, "at risk" gambling, gambling practice evolution, psychiatric comorbidities, gambling trajectory, cognitive distortions, ADHD, addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- MILDT
- Study start
- Apr 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be 18 to 65 years old
- To have gambled during the last year
- To gamble at least one time a year
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Summons of patients and filling questionnaireThe 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. | Other | – |
Primary outcome
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).
2 secondary outcomes
Socio-demographic data
Time frame: 5 years
Clinical data
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Derived from this study: PubMed 32075821Guillou 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.
- Derived from this study: PubMed 25141820Challet-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie GRALL BRONNEC, MD study director
Nantes University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Summons of patients and filling questionnaire in people with Pathological or "at Risk" Gambling, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of psychiatric comorbidities (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207674, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.