Cognitive Remediation Therapy and Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01078129|
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : February 25, 2014
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 or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: cognitive remediation therapy Behavioral: non-CRT||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||December 2010|
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
Sham Comparator: non-CRT
Other Name: no intervention
- cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions) [ Time Frame: before and after CRT (3 months later) ]standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).
- brain functioning (fMRI) [ Time Frame: before and after CRT (3 months later) ]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 ]standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078129
|Hôpital le vinatier|
|Bron, France, 69677|
|Principal Investigator:||Thierry d'amato, MD, PhD||Hopital le Vinatier|