Specific Cognitive Remediation for Schizophrenia (RECOS)

September 2, 2015 updated by: Nicolas FRANCK, Pr, Hôpital le Vinatier

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in executive functioning at week 12
Time Frame: week 12
BADS(Behavioral Assessement of Dysexecutive Functions) total score
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12
Time Frame: week 12
comprehensive neuropsychological assessment
week 12
Change from baseline in symptoms at week 12
Time Frame: week 12
PANSS (Positive And Negative Symptoms Scale)
week 12
Change from baseline in self-esteem at week 12
Time Frame: week 12
Rosenberg scale
week 12
Change from baseline in insight at week 12
Time Frame: week 12
Birchwood scale
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Collaborators

Saint Anne's Hospital
Centre hospitalier Saint Jean de Dieu - ARHM

Investigators

  • Principal Investigator: Nicolas Franck, Hopital Le vinatier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (ESTIMATE)

May 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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