An interventional study of cognitive remediation in Schizophrenia, sponsored by Hôpital le Vinatier. Completed. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-09-03.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment
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 :
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 151 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy
Change from baseline in executive functioning at week 12
BADS(Behavioral Assessement of Dysexecutive Functions) total score
Time frame: week 12
Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12
comprehensive neuropsychological assessment
Time frame: week 12
Change from baseline in symptoms at week 12
PANSS (Positive And Negative Symptoms Scale)
Time frame: week 12
Change from baseline in self-esteem at week 12
Rosenberg scale
Time frame: week 12
Change from baseline in insight at week 12
Birchwood scale
Time frame: week 12
No study locations are listed for this record.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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