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Specific Cognitive Remediation for Schizophrenia (RECOS)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive remediation
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring cognitive rehabilitation, schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    RECOS: 42 hours CR, 14 week-treatment.

    CRT: 42 hours CR, 14 week-treatment

    Arm Description

    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 (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.

    Outcomes

    Primary Outcome Measures

    Change from baseline in executive functioning at week 12
    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
    comprehensive neuropsychological assessment
    Change from baseline in symptoms at week 12
    PANSS (Positive And Negative Symptoms Scale)
    Change from baseline in self-esteem at week 12
    Rosenberg scale
    Change from baseline in insight at week 12
    Birchwood scale

    Full Information

    First Posted
    May 11, 2012
    Last Updated
    September 2, 2015
    Sponsor
    Hôpital le Vinatier
    Collaborators
    Centre hospitalier Saint Jean de Dieu - ARHM, Saint Anne's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01607424
    Brief Title
    Specific Cognitive Remediation for Schizophrenia
    Acronym
    RECOS
    Official Title
    Specific Versus General Cognitive Remediation for Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hôpital le Vinatier
    Collaborators
    Centre hospitalier Saint Jean de Dieu - ARHM, Saint Anne's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    cognitive rehabilitation, schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    151 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RECOS: 42 hours CR, 14 week-treatment.
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    CRT: 42 hours CR, 14 week-treatment
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    cognitive remediation
    Intervention Description
    RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy
    Primary Outcome Measure Information:
    Title
    Change from baseline in executive functioning at week 12
    Description
    BADS(Behavioral Assessement of Dysexecutive Functions) total score
    Time Frame
    week 12
    Secondary Outcome Measure Information:
    Title
    Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12
    Description
    comprehensive neuropsychological assessment
    Time Frame
    week 12
    Title
    Change from baseline in symptoms at week 12
    Description
    PANSS (Positive And Negative Symptoms Scale)
    Time Frame
    week 12
    Title
    Change from baseline in self-esteem at week 12
    Description
    Rosenberg scale
    Time Frame
    week 12
    Title
    Change from baseline in insight at week 12
    Description
    Birchwood scale
    Time Frame
    week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicolas Franck
    Organizational Affiliation
    Hôpital le Vinatier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23583327
    Citation
    Franck N, Duboc C, Sundby C, Amado I, Wykes T, Demily C, Launay C, Le Roy V, Bloch P, Willard D, Todd A, Petitjean F, Foullu S, Briant P, Grillon ML, Deppen P, Verdoux H, Bralet MC, Januel D, Riche B, Roy P; Other members of the Cognitive Remediation Network; Vianin P. Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophr Res. 2013 Jun;147(1):68-74. doi: 10.1016/j.schres.2013.03.009. Epub 2013 Apr 9.
    Results Reference
    result

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    Specific Cognitive Remediation for Schizophrenia

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