Specific Cognitive Remediation for Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: cognitive remediation

• Registration Number: NCT01607424
• Lead Sponsor: Hôpital le Vinatier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-30
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RECOS: 42 hours CR, 14 week-treatment.	cognitive remediation	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.
CRT: 42 hours CR, 14 week-treatment	cognitive remediation	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in executive functioning at week 12	week 12	BADS(Behavioral Assessement of Dysexecutive Functions) total score

Secondary Outcome Measures

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