Cognitive Remediation and Sheltered Employment in Schizophrenia
NCT ID: NCT01891929
Last Updated: 2019-02-25
Study Results
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Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2013-07-31
2018-10-22
Brief Summary
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1. Measuring the efficiency of the cognitive remediation program RECOS (COgnitive REmediation in Schizophrenia) on the capacity of the patients suffering from schizophrenia to improve the integration in sheltered employment (ESAT and EA).
2. Comparing the efficiency of the program of cognitive remediation RECOS (RECOS arm) to the one of an usual program of coverage/care (TAU arm = Treatment As Usual) on integration in sheltered employment of patients suffering from schizophrenia.
3. Realizing a comparative analysis, in both arms, of :
1. the number of working hours achieved in sheltered environment during the 6 months following the two programs (reported to the working time planned by the contract of employment)
2. the duration of such employments in sheltered areas.
4. Estimating the impact of RECOS on the neuropsychological variables, the symptomatology, the consciousness of the disorders(insight), the quality of life and the social autonomy before the treatment (month M0), at the end of the treatment (month M3), and 6 months later (month M9), and looking for a correlation between the improvement of these parameters and sheltered employment.
5. Estimating the impact of cognitive remediation on integration in sheltered employment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RECOS
The RECOS program (COgnitive REmediation for Schizophrenia) was designed by SBT Company and adapted by Vianin et al (2007) for specific use in schizophrenia. It includes computer based and paper and pencil exercises that target 6 main cognitive functions (selective attention; verbal memory; visuo-spatiale attention and memory, working memory, reasoning, and speed of execution) which have been recommended by the MATRICS consensus. Each exercise has 10 difficulty levels. Allocation of the training modules in RECOS is determined according to the standard scores obtained in the comprehensive neuropsychological assessment. Each patient participates in the module corresponding to his/her most altered cognitive area.
RECOS (COgnitive REmediation for Schizophrenia)
Every RECOS patient will benefit, with his therapist, from 2 sessions of 1 hour of training per week over a 14 weeks period (M1 to M3), plus 1 hour per week of task to be realized at home. All in all, it is thus about a training period of 42 hours.
After remediation, the follow-up of the patient will be led by his therapist with monthly appointments during 6 months (M4 to M9).
In parallel, neuropsychological and clinical scores will be assessed before (M0) and after the training period (M3), as well as at the end of the study (M9). Working and relational abilities will be assessed at the beginning and at the end of the working period (M4 and M9).
TAU (Treatment as Usual)
The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by every service of the various inquiring centers involved. No additional session will be proposed.
TAU (Treatment As Usual)
The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by every service of the various inquiring centers involved. No additional session will be proposed.
In parallel, neuropsychological and clinical scores will be assessed before (M0) and after the training period (M3), as well as at the end of the study (M9). Working and relational abilities will be assessed at the beginning and at the end of the working period (M4 and M9).
Interventions
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RECOS (COgnitive REmediation for Schizophrenia)
Every RECOS patient will benefit, with his therapist, from 2 sessions of 1 hour of training per week over a 14 weeks period (M1 to M3), plus 1 hour per week of task to be realized at home. All in all, it is thus about a training period of 42 hours.
After remediation, the follow-up of the patient will be led by his therapist with monthly appointments during 6 months (M4 to M9).
In parallel, neuropsychological and clinical scores will be assessed before (M0) and after the training period (M3), as well as at the end of the study (M9). Working and relational abilities will be assessed at the beginning and at the end of the working period (M4 and M9).
TAU (Treatment As Usual)
The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by every service of the various inquiring centers involved. No additional session will be proposed.
In parallel, neuropsychological and clinical scores will be assessed before (M0) and after the training period (M3), as well as at the end of the study (M9). Working and relational abilities will be assessed at the beginning and at the end of the working period (M4 and M9).
Eligibility Criteria
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Inclusion Criteria
* Schizophrenia according to the criteria of the DSM-IV-TR.
* Project of entry to ESAT or to EA in the 6 weeks which follow.
* IQ \> 70 (F-NART).
* Stable symptomatology during the month preceding the inclusion.
* Psychotropic treatment unchanged during the month preceding the inclusion (change no more than 25 % posology).
* Overdrawn performances in at least one of the 6 functions estimated by the kit of neuropsychological tests.
* French mother tongue.
* Informed and signed consent by the patient.
* Agreement of the guardian (for protected adults).
* Membership in a national insurance scheme.
Exclusion Criteria
* Neurological disorders of vascular, infectious or neurodegenerative origin; dyschromatopsie.
* Taking of medicine with somatic tropism having a cerebral or psychic impact (eg: corticoids).
* Simultaneous participation to any other program of remediation targeting the neurocognitive deficits.
* Resistance to neuroleptic.
* Reading and writing not acquired.
18 Years
50 Years
ALL
No
Sponsors
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Sainte Anne Hospital (Paris)
UNKNOWN
Clermont-de-l'Oise Hospital (Clermont-de-l'Oise)
UNKNOWN
Saint-Egrève Hospital (Saint-Egrève)
UNKNOWN
Centre Hospitalier de Niort
OTHER
Sainte-Marguerite Hospital (Marseille)
UNKNOWN
Centre Hospitalier Henri Laborit
OTHER
University Hospital, Tours
OTHER
Mental Health Center MGEN (Rueil-Malmaison)
UNKNOWN
Nantes University Hospital
OTHER
Mental Health Center MGEN (Lille)
UNKNOWN
Hôpital le Vinatier
OTHER
Responsible Party
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Nicolas FRANCK, Pr
University professor - Hospital practitioner
Principal Investigators
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Nicolas FRANCK, Professor
Role: PRINCIPAL_INVESTIGATOR
University Service of Rehabilitation (SUR) of the Vinatier Hospital
Brice MARTIN, Doctor
Role: STUDY_DIRECTOR
University Service of Rehabilitation (SUR) of the Vinatier Hospital
Isabelle AMADO, Doctor
Role: STUDY_DIRECTOR
Center of Study and Clinical Research (CERC) of the Ste Anne Hospital
Corinne LAUNAY, Doctor
Role: STUDY_DIRECTOR
Center of Study and Clinical Research (CERC) of the Ste Anne Hospital
Marie-Cécile BRALET, Doctor
Role: STUDY_DIRECTOR
Service CRISALID of the Clermont-de-l'Oise's Hospital
Elisabeth GIRAUD-BARO, Doctor
Role: STUDY_DIRECTOR
Saint-Egrève's Hospital
Julien DUBREUCQ, Doctor
Role: STUDY_DIRECTOR
Saint-Egrève's Hospital
Pascal BLOCH, Doctor
Role: STUDY_DIRECTOR
Niort's Hopsital
Christophe LANCON, Professor
Role: STUDY_DIRECTOR
Sainte Marguerite Hospital
Eric FAKRA, Doctor
Role: STUDY_DIRECTOR
Sainte Marguerite Hospital
Jean-Michel ZAKOIAN, Professor
Role: STUDY_CHAIR
Ecole Nationale de la statistique
Christian FRANCQ, Professor
Role: STUDY_CHAIR
Ecole Nationale de la statistique
Pascal VIANIN, Doctor
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Vaudois
Nathalie GUILLARD-BOUHET, Doctor
Role: STUDY_DIRECTOR
Henri Laborit Hospital
Muriel BONAÏTI, Doctor
Role: STUDY_DIRECTOR
Saint Cyr Hospital
Jérome GRAUX, Doctor
Role: STUDY_DIRECTOR
Tours University Hospital
Bernard DUBOUIS, Doctor
Role: STUDY_DIRECTOR
Mental Health Center MGEN (Rueil-Malmaison)
Vincent SCHAER, Doctor
Role: STUDY_DIRECTOR
Mental Health Center MGEN (Rueil-Malmaison)
Jérome SETTON, Doctor
Role: STUDY_DIRECTOR
Mental Health Center MGEN (Rueil-Malmaison)
Vincent DELAUNAY, Doctor
Role: STUDY_DIRECTOR
Nantes University Hospital
Marion CHIRIO-ESPITALIER, Doctor
Role: STUDY_DIRECTOR
Nantes University Hospital
Ingrid DUR, Doctor
Role: STUDY_DIRECTOR
Mental Health Center MGEN (Lille)
Sophie DELILLE, Doctor
Role: STUDY_DIRECTOR
Mental Health Center MGEN (Lille)
Olivier MAZAS, Doctor
Role: STUDY_DIRECTOR
Mental Health Center MGEN (Lille)
Locations
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Hôpital Le Vinatier Pôle Centre
Bron, , France
Hôpital Le Vinatier Pôle Est
Bron, , France
Mental Health Center (MGEN)
Lille, , France
Hôpital Ste Marguerite
Marseille, , France
Nantes University Hospital
Nantes, , France
Centre Hospitalier de Niort
Niort, , France
Hôpital Ste Anne
Paris, , France
Centre Hospitalier Henri Laborit
Poitiers, , France
Mental Health Center (MGEN)
Rueil-Malmaison, , France
Saint-Cyr Hospital
Saint-Cyr-au-Mont-d'Or, , France
Centre Hospitalier de St-Egrève
Saint-Egrève, , France
Centre de Santé Mentale Angevin (CESAME)
Sainte-Gemmes-sur-Loire, , France
Tours University Hospital
Tours, , France
Countries
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References
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Deppen P, Sarrasin Bruchez P, Dukes R, Pellanda V, Vianin P. [Cognitive remediation program for individuals living with schizophrenia (Recos): preliminary results]. Encephale. 2011 Sep;37(4):314-21. doi: 10.1016/j.encep.2011.02.002. Epub 2011 Apr 9. French.
Franck N, Duboc C, Sundby C, Amado I, Wykes T, Demily C, Launay C, Le Roy V, Bloch P, Willard D, Todd A, Petitjean F, Foullu S, Briant P, Grillon ML, Deppen P, Verdoux H, Bralet MC, Januel D, Riche B, Roy P; Other members of the Cognitive Remediation Network; Vianin P. Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophr Res. 2013 Jun;147(1):68-74. doi: 10.1016/j.schres.2013.03.009. Epub 2013 Apr 9.
Other Identifiers
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2012-A01676-37
Identifier Type: -
Identifier Source: org_study_id
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