NCT01891929

Cognitive Remediation and Sheltered Employment in Schizophrenia

Specific Cognitive Remediation for Schizophrenia (RECOS) and Sheltered Employment: a Multicentre Controlled Randomized Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-10-22
• Completion: 2018-10-22
• First posted: 2013-07-03
• Last updated: 2019-02-25

Locations

13 sites across 1 country: France