Cognitive Remediation and Sheltered Employment in Schizophrenia

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.

Conditions

• Chronic Schizophrenia

Interventions

BEHAVIORAL

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).

BEHAVIORAL

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).

Sponsors & Collaborators

• Sainte Anne Hospital (Paris)

  collaborator UNKNOWN

• Clermont-de-l'Oise Hospital (Clermont-de-l'Oise)

  collaborator UNKNOWN

• Saint-Egrève Hospital (Saint-Egrève)

  collaborator UNKNOWN

• Centre Hospitalier de Niort

  collaborator OTHER

• Sainte-Marguerite Hospital (Marseille)

  collaborator UNKNOWN

• Centre Hospitalier Henri Laborit

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• Mental Health Center MGEN (Rueil-Malmaison)

  collaborator UNKNOWN

• Nantes University Hospital

  collaborator OTHER

• Mental Health Center MGEN (Lille)

  collaborator UNKNOWN

• Hôpital le Vinatier

  lead OTHER

Principal Investigators

• Nicolas FRANCK, Professor · University Service of Rehabilitation (SUR) of the Vinatier Hospital

• Brice MARTIN, Doctor · University Service of Rehabilitation (SUR) of the Vinatier Hospital

• Isabelle AMADO, Doctor · Center of Study and Clinical Research (CERC) of the Ste Anne Hospital

• Corinne LAUNAY, Doctor · Center of Study and Clinical Research (CERC) of the Ste Anne Hospital

• Marie-Cécile BRALET, Doctor · Service CRISALID of the Clermont-de-l'Oise's Hospital

• Elisabeth GIRAUD-BARO, Doctor · Saint-Egrève's Hospital

• Julien DUBREUCQ, Doctor · Saint-Egrève's Hospital

• Pascal BLOCH, Doctor · Niort's Hopsital

• Christophe LANCON, Professor · Sainte Marguerite Hospital

• Eric FAKRA, Doctor · Sainte Marguerite Hospital

• Jean-Michel ZAKOIAN, Professor · Ecole Nationale de la statistique

• Christian FRANCQ, Professor · Ecole Nationale de la statistique

• Pascal VIANIN, Doctor · Centre Hospitalier Universitaire Vaudois

• Nathalie GUILLARD-BOUHET, Doctor · Henri Laborit Hospital

• Muriel BONAÏTI, Doctor · Saint Cyr Hospital

• Jérome GRAUX, Doctor · Tours University Hospital

• Bernard DUBOUIS, Doctor · Mental Health Center MGEN (Rueil-Malmaison)

• Vincent SCHAER, Doctor · Mental Health Center MGEN (Rueil-Malmaison)

• Jérome SETTON, Doctor · Mental Health Center MGEN (Rueil-Malmaison)

• Vincent DELAUNAY, Doctor · Nantes University Hospital

• Marion CHIRIO-ESPITALIER, Doctor · Nantes University Hospital

• Ingrid DUR, Doctor · Mental Health Center MGEN (Lille)

• Sophie DELILLE, Doctor · Mental Health Center MGEN (Lille)

• Olivier MAZAS, Doctor · Mental Health Center MGEN (Lille)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2018-10-22

Completion

2018-10-22

Countries

• France

Study Locations