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

February 22, 2010
February 24, 2014
January 2006
March 2008   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01078129 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Cognitive Remediation Therapy and Schizophrenia
Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Schizophrenia
  • 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
  • Behavioral: non-CRT
    waiting list
    Other Name: no intervention
  • 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
    Intervention: Behavioral: cognitive remediation therapy
  • Sham Comparator: non-CRT
    no intervention
    Intervention: Behavioral: non-CRT
Bor J, Brunelin J, d'Amato T, Costes N, Suaud-Chagny MF, Saoud M, Poulet E. How can cognitive remediation therapy modulate brain activations in schizophrenia? An fMRI study. Psychiatry Res. 2011 Jun 30;192(3):160-6. doi: 10.1016/j.pscychresns.2010.12.004. Epub 2011 May 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
December 2010
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01078129
2005-094B
No
Hôpital le Vinatier
Hôpital le Vinatier
  • University Hospital, Grenoble
  • University Hospital, Clermont-Ferrand
Principal Investigator: Thierry d'amato, MD, PhD Hopital le Vinatier
Hôpital le Vinatier
February 2014

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