Specific Cognitive Remediation for Schizophrenia (RECOS)

This study has been completed.
Sponsor:
Collaborators:
Centre hospitalier Saint Jean de Dieu - ARHM
Saint Anne's Hospital
Information provided by (Responsible Party):
Nicolas FRANCK, Pr, Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT01607424
First received: May 11, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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 Intervention
Schizophrenia
Behavioral: cognitive remediation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Specific Versus General Cognitive Remediation for Schizophrenia

Resource links provided by NLM:


Further study details as provided by Hôpital le Vinatier:

Primary Outcome Measures:
  • Change from baseline in executive functioning at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    BADS(Behavioral Assessement of Dysexecutive Functions) total score


Secondary Outcome Measures:
  • Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    comprehensive neuropsychological assessment

  • Change from baseline in symptoms at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    PANSS (Positive And Negative Symptoms Scale)

  • Change from baseline in self-esteem at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Rosenberg scale

  • Change from baseline in insight at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Birchwood scale


Enrollment: 151
Study Start Date: December 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 11, 2012
Last Updated: July 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Hôpital le Vinatier:
cognitive rehabilitation
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 20, 2014