NARCIS COGNITIVE FOR COGNITIVE DISORDERS OF SCHIZOPHRENIA

Study Overview
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Brief Summary
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This study evaluates the effect of a cognitive remediation program designed for patients suffering from a schizophrenia spectrum disorder ; on neurocognitive, social cognitive and metacognitive functions. In this double-blind (patients, outcomes assessors) controlled randomized trial the investigators compare patients receiving Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz] to patients benefiting from recovery-oriented therapy [ThOR]. Patients are treated for two months and monitored for four months.

Detailed Description
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Evaluation of the specific therapeutic efficacy of the Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz] on neurocognitive deficits, social cognition and metacognition deficits of patients with a schizophrenia spectrum disorder.

Official Title
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Neuropsychological Assessment of Remediation for Cognitive Impairment in Schizophrénie

Conditions
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Schizophrenia Disorder

Intervention / Treatment
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* Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder
* Other: Recovery-Oriented Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia Disorder diagnosis, according to Diagnostic and Statistical Manual of mental disorders - Fifth edition (DSM-V) - Patient stabilized in terms of positive and negative symptomatology (absence or presence of weak positive and negative symptoms) Positive and Negative stable symptoms (no or few positive and negative symptoms) Stable and effective minimum dose of medication (antipsychotic) for the last three months Cognitive complaint expressed by the patient Informed consent form read, initialed and signed Understanding of spoken and read French Patient registered on the social welfare system Exclusion Criteria: Other diagnosis at the forefront than Schizophrenia of the DSM-V Medical history neurological disorder resulting in hospitalization Acute episode in the last three month Somatic disorders resulting in cognitive impairment Engagement in a research protocol either currently or over the last month Neuropsychological assessment evaluation during the last six month Patients under the protection of a conservator (simple or reinforced) Individuals in vulnerable circumstances

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]<br>to inform the patient about cognitive impairments and their repercussions ; to train the patient in problem-solving skills through exercices ; to implement strategies in daily life. Duration : two month. Frequency : Two one hour individual sessions and one hour of at-home training per week. Modalities : pen and papers exercices (tools (token, cards, maps and chessboard). Modules : Psychoeducation, Attention, Memory, Executive functions, Social cognition and metacognition, Functional impairments | Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder<br>* The first group will have [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder<br>* Other names: [Eco-Sz];|
| Active Comparator: [THoR] Recovery-Oriented Therapy<br>Individual psychotherapy sessions focussing on autonomy in daily life, management of mood disorders' and functional impact, social skills, motivation and the regulation of sleep and daily activities | Other: Recovery-Oriented Therapy<br>* The second group will have [THoR] Recovery-Oriented Therapy<br>* Other names: [THoR];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-500 | The Mini International Neuropsychiatric Interview | pre-inclusion | 
| CTQ | Childhood Trauma questionnaire | pre-inclusion | 
| PANSS | Positive and Negative Syndrome Scale | pre-inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EESEP | Self-Efficacity Rating Scale | First week | 
| EESEP | Self-Efficacity Rating Scale | Ten week | 
| EESEP | Self-Efficacity Rating Scale | Eighteen week | 
| EESEP | Self-Efficacity Rating Scale | Twenty six week | 
| ERF | Functional Impact Scale | First week | 
| ERF | Functional Impact Scale | Ten week | 
| ERF | Functional Impact Scale | Eighteen week | 
| ERF | Functional Impact Scale | Twenty six week | 
| ERF-CS | Functional Impact Scale for Social Cognition disorders | First week | 
| ERF-CS | Functional Impact Scale for Social Cognition disorders | Ten week | 
| ERF-CS | Functional Impact Scale for Social Cognition disorders | Eighteen week | 
| ERF-CS | Functional Impact Scale for Social Cognition disorders | Twenty six week | 
| MCQ-30 | Short French Meta-Cognitions Questionnaire (MCQ-30) | First week | 
| MCQ-30 | Short French Meta-Cognitions Questionnaire (MCQ-30) | Ten week | 
| MCQ-30 | Short French Meta-Cognitions Questionnaire (MCQ-30) | Eighteen week | 
| MCQ-30 | Short French Meta-Cognitions Questionnaire (MCQ-30) | Twenty six week | 
| QFS | Social Functioning Questionnaire | First week | 
| QFS | Social Functioning Questionnaire | Ten week | 
| QFS | Social Functioning Questionnaire | Eighteen week | 
| QFS | Social Functioning Questionnaire | Twenty six week | 
| SAIQ | Self-Appraisal of Illness Questionnaire (SAIQ) | First week | 
| SAIQ | Self-Appraisal of Illness Questionnaire (SAIQ) | Ten week | 
| SAIQ | Self-Appraisal of Illness Questionnaire (SAIQ) | Eighteen week | 
| SAIQ | Self-Appraisal of Illness Questionnaire (SAIQ) | Twenty six week | 
| SCS | Revised Self-Consciousness Scale (SCS) | First week | 
| SCS | Revised Self-Consciousness Scale (SCS) | Ten week | 
| SCS | Revised Self-Consciousness Scale (SCS) | Eighteen week | 
| SCS | Revised Self-Consciousness Scale (SCS) | Twenty six week | 
| SDS | Social Desirability Scale | First week | 
| SDS | Social Desirability Scale | Ten week | 
| SDS | Social Desirability Scale | Eighteen week | 
| SDS | Social Desirability Scale | Twenty six week | 
| STORI | Stage of Recovery Instrument | First week | 
| STORI | Stage of Recovery Instrument | Ten week | 
| STORI | Stage of Recovery Instrument | Eighteen week | 
| STORI | Stage of Recovery Instrument | Twenty six week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, neurocognition, cognition sociale, metacognition, cognitive remediation