Cognitive Remediation Therapy and Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: cognitive remediation therapy
* Behavioral: non-CRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: behavior therapy - CRT<br>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<br>* program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software<br>* Other names: behavioral intervention;|
| Sham Comparator: non-CRT<br>no intervention | Behavioral: non-CRT<br>* waiting list<br>* Other names: no intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions) | standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT). | before and after CRT (3 months later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain functioning (fMRI) | 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. | before and after CRT (3 months later) | 
| schizophrenia symptoms | standardised psychometric scale measuring Positive an Negative Symptoms (PANSS) | before CRT and 3 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive deficits