Cognitive Remediation Therapy and Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Grenoble
University Hospital, Clermont-Ferrand
Information provided by (Responsible Party):
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT01078129
First received: February 22, 2010
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

Objectives:

The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with schizophrenia.


Condition Intervention
Schizophrenia
Behavioral: cognitive remediation therapy
Behavioral: non-CRT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Hôpital le Vinatier:

Primary Outcome Measures:
  • cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions) [ Time Frame: before and after CRT (3 months later) ] [ Designated as safety issue: No ]
    standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).


Secondary Outcome Measures:
  • brain functioning (fMRI) [ Time Frame: before and after CRT (3 months later) ] [ Designated as safety issue: No ]
    fMRI during a n-back task, 2 times, before CRT and 3 months later. The 2 sub-groups of 15 patients will be compared with healthy subjects performances at the same task.

  • schizophrenia symptoms [ Time Frame: before CRT and 3 months later ] [ Designated as safety issue: No ]
    standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)


Enrollment: 77
Study Start Date: January 2006
Study Completion Date: December 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: behavior therapy - CRT
behavior program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions) by means REHACOM® software
Behavioral: cognitive remediation therapy
program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software
Other Names:
  • CRT
  • cognitive remediation therapy
  • behavioral intervention
Sham Comparator: non-CRT
no intervention
Behavioral: non-CRT
waiting list
Other Name: no intervention

Detailed Description:

Methods:

In a 2 arms blind study versus sham,80 patients with schizophrenia were enrolled in a program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software. Measures of cognitive functioning using the Cogtest® battery as well as social autonomy (Social Autonomy Scale, EAS) and schizophrenia symptoms (Positive And Negative Syndrome Scale, PANSS) were undertaken at the beginning and the end of the meetings of remediation.

Among those 80 participants, 30 patients to (15 active / 15 sham) were randomized to participate in an fMRI study in order to investigate the impact of such CRT program on brain functioning (n-back task before CRT and 3 months later).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • schizophrenia (DSM IV criteria)
  • remitted symptoms
  • french language
  • informed consent

Exclusion Criteria:

  • addiction, neurological disease
  • only for second randomized patient participating in MRI study (n=30) : MRI counterindications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078129

Locations
France
Hôpital le vinatier
Bron, France, 69677
Sponsors and Collaborators
Hôpital le Vinatier
University Hospital, Grenoble
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Thierry d'amato, MD, PhD Hopital le Vinatier
  More Information

No publications provided by Hôpital le Vinatier

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT01078129     History of Changes
Other Study ID Numbers: 2005-094B
Study First Received: February 22, 2010
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hôpital le Vinatier:
cognitive deficits

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

ClinicalTrials.gov processed this record on April 17, 2014