Specific Cognitive Remediation for Schizophrenia

Study Overview
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Brief Summary
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Rationale: Cognitive deficits are a core feature in schizophrenia. Conventional treatments (antipsychotic medication and psychological treatments) have limited effects so cognitive remediation programs were designed to alleviate the problems. Interventions typically involve a variety of exercises in a paper and pencil or a computerized format with a growing number of specialized computer programs now being developed. However, many of these programs lack specificity which does not allow an individual's specific needs to be addressed. More targeted interventions might increase the effects of therapy so RECOS - COgnitive REmediation for Schizophrenia - was developed to fit this gap. Methods: This is a multicenter, randomized, controlled study comparing patients aged 18 to 45 years suffering from schizophrenia according to DSM-IV-TR. RECOS will be compared to an already validated program (CRT). 220 patients will be randomized as follows : Arm 1 : RECOS (42 h) Arm 2 : CRT (42 h) The recruitment is performed by psychiatrists in Lyon, Paris, Clermont-de-l'Oise, Niort, Bordeaux, Ville-Evrard and Lausanne.

Official Title
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Specific Versus General Cognitive Remediation for Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: cognitive remediation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women aged 18 to 45 years French speaker or French schooling since 7 years clinical stability diagnosis of schizophrenia Exclusion Criteria: visual or auditory disorder history of neurological illness or trauma alcohol or drug dependence mental retardation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECOS: 42 hours CR, 14 week-treatment.<br>RECOS(Cognitive Remediation for Schizophrenia) exercises were 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 5 main cognitive functions. RECOS modules focus on the relevant cognitive domains, which have been recommended by the MATRICS consensus. Each exercise has 10 difficulty levels. Allocation of the training modules in RECOS was determined according to the standard scores obtained in the comprehensive neuropsychological assessment. Each patient participated in the module corresponding to his/her most altered cognitive area. | Behavioral: cognitive remediation<br>* RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy<br>|
| Active Comparator: CRT: 42 hours CR, 14 week-treatment<br>CRT (Cognitive Remediation Therapy) exercises are the ones used by Wykes et al (1999). The CRT method consists of 3 modules: flexibility, memory (A and B) and planning (A and B). Each module involves a series of paper and pencil exercises with parallel forms providing with gradual difficulty. | Behavioral: cognitive remediation<br>* RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in executive functioning at week 12 | BADS(Behavioral Assessement of Dysexecutive Functions) total score | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12 | comprehensive neuropsychological assessment | week 12 | 
| Change from baseline in symptoms at week 12 | PANSS (Positive And Negative Symptoms Scale) | week 12 | 
| Change from baseline in self-esteem at week 12 | Rosenberg scale | week 12 | 
| Change from baseline in insight at week 12 | Birchwood scale | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive rehabilitation, schizophrenia