Clinical trial NCT01891929: Cognitive Remediation and Sheltered Employment in Schizophrenia
Official title: Specific Cognitive Remediation for Schizophrenia (RECOS) and Sheltered Employment: a Multicentre Controlled Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Schizophrenia
Keywords: Schizophrenia
Cognitive Remediation
Working abilities and social functioning
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
Collaborators: name: Sainte Anne Hospital (Paris)
name: Clermont-de-l'Oise Hospital (Clermont-de-l'Oise)
name: Saint-Egrève Hospital (Saint-Egrève)
name: Centre Hospitalier de Niort
name: Sainte-Marguerite Hospital (Marseille)
name: Centre Hospitalier Henri Laborit
name: University Hospital, Tours
name: Mental Health Center MGEN (Rueil-Malmaison)
name: Nantes University Hospital
name: Mental Health Center MGEN (Lille)
First posted: 2013-07-03
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study, driven on schizophrenic patients, is aimed at :

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.


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 50 years.
* 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:

* Dependence and recent abuses of cannabis (\> 2 / week) or in any other substance (according to the criteria of the DSM-IV-TR), except tobacco.
* 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.

Primary outcomes:
measure: Number of worked hours during the first 6 months of the contract of employment
timeFrame: Outcome measures are daily assessed during 6 months (M4 to M9)
Secondary outcomes:
measure: Compared evolution of the neuropsychological and clinical balance sheets between the beginning and the end of the Cognitive Remediation period (or the end of the "Treatment As Usual" period for the TAU arm)
timeFrame: Scores are assessed 3 times: at M0 (Inclusion), at M3 (after Cognitive Remediation or Treatment As Usual), and at M9 (6 month after end of treatment).
measure: Compared evolution of the neuropsychological and clinical balance sheets during the 6 first months of working contract (i.e. following the end of the training Cognitive Remediation period or after the "Treatment As Usual" period for the TAU arm).
timeFrame: Neuropsychological and clinical scores are assessed twice : at M3 (after Cognitive Remediation or Treatment As Usual), and at M9 (after 6 months of working period). Occupational integration (EATR) is assessed twice at the same moments (M3 & M9).
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Le Vinatier Pôle Centre
city: Bron
country: France
facility: Hôpital Le Vinatier Pôle Est
city: Lille
country: France
facility: Mental Health Center (MGEN)
city: Marseille
country: France
facility: Hôpital Ste Marguerite
city: Nantes
country: France
facility: Nantes University Hospital
city: Niort
country: France
facility: Centre Hospitalier de Niort
city: Paris
country: France
facility: Hôpital Ste Anne
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
city: Rueil-Malmaison
country: France
facility: Mental Health Center (MGEN)
city: Saint-Cyr-au-Mont-d'Or
country: France
facility: Saint-Cyr Hospital
city: Saint-Egrève
country: France
facility: Centre Hospitalier de St-Egrève
city: Sainte-Gemmes-sur-Loire
country: France
facility: Centre de Santé Mentale Angevin (CESAME)
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: University Service of Rehabilitation (SUR) of the Vinatier Hospital
name: Nicolas FRANCK, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Service of Rehabilitation (SUR) of the Vinatier Hospital
name: Brice MARTIN, Doctor
role: STUDY_DIRECTOR
affiliation: Center of Study and Clinical Research (CERC) of the Ste Anne Hospital
name: Isabelle AMADO, Doctor
role: STUDY_DIRECTOR
affiliation: Center of Study and Clinical Research (CERC) of the Ste Anne Hospital
name: Corinne LAUNAY, Doctor
role: STUDY_DIRECTOR
affiliation: Service CRISALID of the Clermont-de-l'Oise's Hospital
name: Marie-Cécile BRALET, Doctor
role: STUDY_DIRECTOR
affiliation: Saint-Egrève's Hospital
name: Elisabeth GIRAUD-BARO, Doctor
role: STUDY_DIRECTOR
affiliation: Saint-Egrève's Hospital
name: Julien DUBREUCQ, Doctor
role: STUDY_DIRECTOR
affiliation: Niort's Hopsital
name: Pascal BLOCH, Doctor
role: STUDY_DIRECTOR
affiliation: Sainte Marguerite Hospital
name: Christophe LANCON, Professor
role: STUDY_DIRECTOR
affiliation: Sainte Marguerite Hospital
name: Eric FAKRA, Doctor
role: STUDY_DIRECTOR
affiliation: Ecole Nationale de la statistique
name: Jean-Michel ZAKOIAN, Professor
role: STUDY_CHAIR
affiliation: Ecole Nationale de la statistique
name: Christian FRANCQ, Professor
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire Vaudois
name: Pascal VIANIN, Doctor
role: STUDY_CHAIR
affiliation: Henri Laborit Hospital
name: Nathalie GUILLARD-BOUHET, Doctor
role: STUDY_DIRECTOR
affiliation: Saint Cyr Hospital
name: Muriel BONAÏTI, Doctor
role: STUDY_DIRECTOR
affiliation: Tours University Hospital
name: Jérome GRAUX, Doctor
role: STUDY_DIRECTOR
affiliation: Mental Health Center MGEN (Rueil-Malmaison)
name: Bernard DUBOUIS, Doctor
role: STUDY_DIRECTOR
affiliation: Mental Health Center MGEN (Rueil-Malmaison)
name: Vincent SCHAER, Doctor
role: STUDY_DIRECTOR
affiliation: Mental Health Center MGEN (Rueil-Malmaison)
name: Jérome SETTON, Doctor
role: STUDY_DIRECTOR
affiliation: Nantes University Hospital
name: Vincent DELAUNAY, Doctor
role: STUDY_DIRECTOR
affiliation: Nantes University Hospital
name: Marion CHIRIO-ESPITALIER, Doctor
role: STUDY_DIRECTOR
affiliation: Mental Health Center MGEN (Lille)
name: Ingrid DUR, Doctor
role: STUDY_DIRECTOR
affiliation: Mental Health Center MGEN (Lille)
name: Sophie DELILLE, Doctor
role: STUDY_DIRECTOR
affiliation: Mental Health Center MGEN (Lille)
name: Olivier MAZAS, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.