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Specific Cognitive Remediation for Schizophrenia (RECOS)

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ClinicalTrials.gov Identifier: NCT01607424
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : September 3, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Schizophrenia Behavioral: cognitive remediation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Specific Versus General Cognitive Remediation for Schizophrenia
Study Start Date : December 2008
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: RECOS: 42 hours CR, 14 week-treatment.
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
RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy
Active Comparator: CRT: 42 hours CR, 14 week-treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in executive functioning at week 12 [ Time Frame: week 12 ]
    BADS(Behavioral Assessement of Dysexecutive Functions) total score


Secondary Outcome Measures :
  1. Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12 [ Time Frame: week 12 ]
    comprehensive neuropsychological assessment

  2. Change from baseline in symptoms at week 12 [ Time Frame: week 12 ]
    PANSS (Positive And Negative Symptoms Scale)

  3. Change from baseline in self-esteem at week 12 [ Time Frame: week 12 ]
    Rosenberg scale

  4. Change from baseline in insight at week 12 [ Time Frame: week 12 ]
    Birchwood scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607424


Sponsors and Collaborators
Hôpital le Vinatier
Centre hospitalier Saint Jean de Dieu - ARHM
Saint Anne's Hospital
Investigators
Principal Investigator: Nicolas Franck Hôpital le Vinatier
More Information

Publications:
Responsible Party: Nicolas FRANCK, Pr, Professor (Claude Bernard University), head of department (Hôpital le Vinatier), principal investigator, Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT01607424     History of Changes
Other Study ID Numbers: RECOS
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015

Keywords provided by Nicolas FRANCK, Pr, Hôpital le Vinatier:
cognitive rehabilitation
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders