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

May 11, 2012
July 2, 2013
December 2008
October 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01607424 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Specific Cognitive Remediation for Schizophrenia
Specific Versus General Cognitive Remediation for Schizophrenia

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
Behavioral: cognitive remediation
RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy
  • 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.
    Intervention: Behavioral: cognitive remediation
  • 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.
    Intervention: Behavioral: cognitive remediation
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; Members of 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01607424
RECOS
No
Nicolas FRANCK, Pr, Hôpital le Vinatier
Hôpital le Vinatier
  • Centre hospitalier Saint Jean de Dieu - ARHM
  • Saint Anne's Hospital
Principal Investigator: Nicolas Franck Hôpital le Vinatier
Hôpital le Vinatier
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP