Specific Cognitive Remediation for Schizophrenia

NCT01607424 | Completed

• 1 other identifier: RECOS
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

cognitive rehabilitation; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in executive functioning at week 12

  BADS(Behavioral Assessement of Dysexecutive Functions) total score

  week 12

Secondary Outcomes (4)

• Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12

  week 12

• Change from baseline in symptoms at week 12

  week 12

• Change from baseline in self-esteem at week 12

  week 12

• Change from baseline in insight at week 12

  week 12

Study Arms (2)

RECOS: 42 hours CR, 14 week-treatment.

EXPERIMENTAL

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: 42 hours CR, 14 week-treatment

ACTIVE COMPARATOR

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

Interventions

cognitive remediation BEHAVIORAL

RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy

CRT: 42 hours CR, 14 week-treatment; RECOS: 42 hours CR, 14 week-treatment.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• men and women aged 18 to 45 years
• French speaker or French schooling since 7 years
• clinical stability
• diagnosis of schizophrenia

You may not qualify if:

• visual or auditory disorder
• history of neurological illness or trauma
• alcohol or drug dependence
• mental retardation

Sponsors & Collaborators

• Hôpital le Vinatier: lead
• Centre hospitalier Saint Jean de Dieu - ARHM: collaborator
• Saint Anne's Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 23583327 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nicolas Franck

  Hôpital le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Claude Bernard University), head of department (Hôpital le Vinatier), principal investigator

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 30, 2012
• Study Start: December 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 3, 2015

Record last verified: 2015-09