Back to resultsNARCIS COGNITIVE FOR COGNITIVE DISORDERS OF SCHIZOPHRENIA (NARCIS)
Primary Purpose
Schizophrenia Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
[Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder
Recovery-Oriented Therapy
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia Disorder focused on measuring Schizophrenia, neurocognition, cognition sociale, metacognition, cognitive remediation
Eligibility Criteria
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
Sites / Locations
- Ch Ville Evrard
- URC Ville Evrard
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]
[THoR] Recovery-Oriented Therapy
Arm Description
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
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
Outcomes
Primary Outcome Measures
Mini-500
The Mini International Neuropsychiatric Interview
CTQ
Childhood Trauma questionnaire
PANSS
Positive and Negative Syndrome Scale
Secondary Outcome Measures
EESEP
Self-Efficacity Rating Scale
EESEP
Self-Efficacity Rating Scale
EESEP
Self-Efficacity Rating Scale
EESEP
Self-Efficacity Rating Scale
ERF
Functional Impact Scale
ERF
Functional Impact Scale
ERF
Functional Impact Scale
ERF
Functional Impact Scale
ERF-CS
Functional Impact Scale for Social Cognition disorders
ERF-CS
Functional Impact Scale for Social Cognition disorders
ERF-CS
Functional Impact Scale for Social Cognition disorders
ERF-CS
Functional Impact Scale for Social Cognition disorders
MCQ-30
Short French Meta-Cognitions Questionnaire (MCQ-30)
MCQ-30
Short French Meta-Cognitions Questionnaire (MCQ-30)
MCQ-30
Short French Meta-Cognitions Questionnaire (MCQ-30)
MCQ-30
Short French Meta-Cognitions Questionnaire (MCQ-30)
QFS
Social Functioning Questionnaire
QFS
Social Functioning Questionnaire
QFS
Social Functioning Questionnaire
QFS
Social Functioning Questionnaire
SAIQ
Self-Appraisal of Illness Questionnaire (SAIQ)
SAIQ
Self-Appraisal of Illness Questionnaire (SAIQ)
SAIQ
Self-Appraisal of Illness Questionnaire (SAIQ)
SAIQ
Self-Appraisal of Illness Questionnaire (SAIQ)
SCS
Revised Self-Consciousness Scale (SCS)
SCS
Revised Self-Consciousness Scale (SCS)
SCS
Revised Self-Consciousness Scale (SCS)
SCS
Revised Self-Consciousness Scale (SCS)
SDS
Social Desirability Scale
SDS
Social Desirability Scale
SDS
Social Desirability Scale
SDS
Social Desirability Scale
STORI
Stage of Recovery Instrument
STORI
Stage of Recovery Instrument
STORI
Stage of Recovery Instrument
STORI
Stage of Recovery Instrument
Full Information
NCT ID
NCT04608032
First Posted
October 23, 2020
Last Updated
October 23, 2020
Sponsor
Centre hospitalier de Ville-Evrard, France
1. Study Identification
Unique Protocol Identification Number
NCT04608032
Brief Title
NARCIS COGNITIVE FOR COGNITIVE DISORDERS OF SCHIZOPHRENIA
Acronym
NARCIS
Official Title
Neuropsychological Assessment of Remediation for Cognitive Impairment in Schizophrénie
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
September 8, 2021 (Anticipated)
Study Completion Date
September 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de Ville-Evrard, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Disorder
Keywords
Schizophrenia, neurocognition, cognition sociale, metacognition, cognitive remediation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]
Arm Type
Experimental
Arm Description
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
Arm Title
[THoR] Recovery-Oriented Therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
[Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder
Other Intervention Name(s)
[Eco-Sz]
Intervention Description
The first group will have [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder
Intervention Type
Other
Intervention Name(s)
Recovery-Oriented Therapy
Other Intervention Name(s)
[THoR]
Intervention Description
The second group will have [THoR] Recovery-Oriented Therapy
Primary Outcome Measure Information:
Title
Mini-500
Description
The Mini International Neuropsychiatric Interview
Time Frame
pre-inclusion
Title
CTQ
Description
Childhood Trauma questionnaire
Time Frame
pre-inclusion
Title
PANSS
Description
Positive and Negative Syndrome Scale
Time Frame
pre-inclusion
Secondary Outcome Measure Information:
Title
EESEP
Description
Self-Efficacity Rating Scale
Time Frame
First week
Title
EESEP
Description
Self-Efficacity Rating Scale
Time Frame
Ten week
Title
EESEP
Description
Self-Efficacity Rating Scale
Time Frame
Eighteen week
Title
EESEP
Description
Self-Efficacity Rating Scale
Time Frame
Twenty six week
Title
ERF
Description
Functional Impact Scale
Time Frame
First week
Title
ERF
Description
Functional Impact Scale
Time Frame
Ten week
Title
ERF
Description
Functional Impact Scale
Time Frame
Eighteen week
Title
ERF
Description
Functional Impact Scale
Time Frame
Twenty six week
Title
ERF-CS
Description
Functional Impact Scale for Social Cognition disorders
Time Frame
First week
Title
ERF-CS
Description
Functional Impact Scale for Social Cognition disorders
Time Frame
Ten week
Title
ERF-CS
Description
Functional Impact Scale for Social Cognition disorders
Time Frame
Eighteen week
Title
ERF-CS
Description
Functional Impact Scale for Social Cognition disorders
Time Frame
Twenty six week
Title
MCQ-30
Description
Short French Meta-Cognitions Questionnaire (MCQ-30)
Time Frame
First week
Title
MCQ-30
Description
Short French Meta-Cognitions Questionnaire (MCQ-30)
Time Frame
Ten week
Title
MCQ-30
Description
Short French Meta-Cognitions Questionnaire (MCQ-30)
Time Frame
Eighteen week
Title
MCQ-30
Description
Short French Meta-Cognitions Questionnaire (MCQ-30)
Time Frame
Twenty six week
Title
QFS
Description
Social Functioning Questionnaire
Time Frame
First week
Title
QFS
Description
Social Functioning Questionnaire
Time Frame
Ten week
Title
QFS
Description
Social Functioning Questionnaire
Time Frame
Eighteen week
Title
QFS
Description
Social Functioning Questionnaire
Time Frame
Twenty six week
Title
SAIQ
Description
Self-Appraisal of Illness Questionnaire (SAIQ)
Time Frame
First week
Title
SAIQ
Description
Self-Appraisal of Illness Questionnaire (SAIQ)
Time Frame
Ten week
Title
SAIQ
Description
Self-Appraisal of Illness Questionnaire (SAIQ)
Time Frame
Eighteen week
Title
SAIQ
Description
Self-Appraisal of Illness Questionnaire (SAIQ)
Time Frame
Twenty six week
Title
SCS
Description
Revised Self-Consciousness Scale (SCS)
Time Frame
First week
Title
SCS
Description
Revised Self-Consciousness Scale (SCS)
Time Frame
Ten week
Title
SCS
Description
Revised Self-Consciousness Scale (SCS)
Time Frame
Eighteen week
Title
SCS
Description
Revised Self-Consciousness Scale (SCS)
Time Frame
Twenty six week
Title
SDS
Description
Social Desirability Scale
Time Frame
First week
Title
SDS
Description
Social Desirability Scale
Time Frame
Ten week
Title
SDS
Description
Social Desirability Scale
Time Frame
Eighteen week
Title
SDS
Description
Social Desirability Scale
Time Frame
Twenty six week
Title
STORI
Description
Stage of Recovery Instrument
Time Frame
First week
Title
STORI
Description
Stage of Recovery Instrument
Time Frame
Ten week
Title
STORI
Description
Stage of Recovery Instrument
Time Frame
Eighteen week
Title
STORI
Description
Stage of Recovery Instrument
Time Frame
Twenty six week
Other Pre-specified Outcome Measures:
Title
GREFEX battery
Description
GREFEX battery Stroop Test, Trail Making Test, Verbal Fluency Neuropsychological battery test assessing executive function
Time Frame
First week
Title
GREFEX battery
Description
GREFEX battery Stroop Test, Trail Making Test, Verbal Fluency Neuropsychological battery test assessing executive function
Time Frame
Ten week
Title
GREFEX battery
Description
GREFEX battery Stroop Test, Trail Making Test, Verbal Fluency Neuropsychological battery test assessing executive function
Time Frame
Eighteen week
Title
GREFEX battery
Description
GREFEX battery Stroop Test, Trail Making Test, Verbal Fluency Neuropsychological battery test assessing executive function
Time Frame
Twenty six week
Title
FAUX-PAS Test
Description
A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters.
Time Frame
First week
Title
FAUX-PAS Test
Description
A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters.
Time Frame
Ten week week
Title
FAUX-PAS Test
Description
A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters.
Time Frame
Eighteen week week
Title
FAUX-PAS Test
Description
A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters.
Time Frame
Twenty six week
Title
The Rey/Taylor complex figure test
Description
The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory.
Time Frame
First week
Title
The Rey/Taylor complex figure test
Description
The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory.
Time Frame
Ten week
Title
The Rey/Taylor complex figure test
Description
The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory.
Time Frame
Eighteen week
Title
The Rey/Taylor complex figure test
Description
The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory.
Time Frame
Twenty six week
Title
Go/NoGo test
Description
The test is used to measure capacity for sustained attention, inhibition and response control.
Time Frame
First week
Title
Go/NoGo test
Description
The test is used to measure capacity for sustained attention, inhibition and response control.
Time Frame
Ten week
Title
Go/NoGo test
Description
The test is used to measure capacity for sustained attention, inhibition and response control.
Time Frame
Eighteen week
Title
Go/NoGo test
Description
The test is used to measure capacity for sustained attention, inhibition and response control.
Time Frame
Twenty six week
Title
MEM IV Logical Memory
Description
Composite score of the Weschler Memory Scale - fourth edition
Time Frame
First week
Title
MEM IV Logical Memory
Description
Composite score of the Weschler Memory Scale - fourth edition
Time Frame
Ten week
Title
MEM IV Logical Memory
Description
Composite score of the Weschler Memory Scale - fourth edition
Time Frame
Eighteen week
Title
MEM IV Logical Memory
Description
Composite score of the Weschler Memory Scale - fourth edition
Time Frame
Twenty six week
Title
MEM IV Symbol Memory
Description
Composite score of the Weschler Memory Scale - fourth edition
Time Frame
First week
Title
MEM IV Symbol Memory
Description
Composite score of the Weschler Memory Scale - fourth edition
Time Frame
Ten week
Title
MEM IV Symbol Memory
Description
Composite score of the Weschler Memory Scale - fourth edition
Time Frame
Eighteen week
Title
MEM IV Symbol Memory
Description
Composite score of the Weschler Memory Scale - fourth edition
Time Frame
Twenty six week
Title
The Balloon Analogue Risk Task
Description
The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior.
Time Frame
First week
Title
The Balloon Analogue Risk Task
Description
The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior.
Time Frame
Ten week
Title
The Balloon Analogue Risk Task
Description
The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior.
Time Frame
Eighteen week
Title
The Balloon Analogue Risk Task
Description
The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior.
Time Frame
Twenty six week
Title
D2 Test
Description
The test is neuropsychological measure of selective and sustained attention and visual scanning speed.
Time Frame
First week
Title
D2 Test
Description
The test is neuropsychological measure of selective and sustained attention and visual scanning speed.
Time Frame
Ten week
Title
D2 Test
Description
The test is neuropsychological measure of selective and sustained attention and visual scanning speed.
Time Frame
Eighteen week
Title
D2 Test
Description
The test is neuropsychological measure of selective and sustained attention and visual scanning speed.
Time Frame
Twenty six week
Title
ToM-15
Description
The test is a task assessing theory of mind abilities. you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location.
Time Frame
First week
Title
ToM-15
Description
The test is a task assessing theory of mind abilities. you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location.
Time Frame
Ten week
Title
ToM-15
Description
The test is a task assessing theory of mind abilities. you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location.
Time Frame
Eighteen week
Title
ToM-15
Description
The test is a task assessing theory of mind abilities. you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location.
Time Frame
Twenty six week
Title
Tower of Hanoi
Description
The Tower of Hanoi is used to measure capacity on problem solving and planning, self-consciousness and control.
Time Frame
First week
Title
Tower of Hanoi
Description
The Tower of Hanoi is used to measure capacity on problem solving and planning, self-consciousness and control.
Time Frame
Ten week
Title
Tower of Hanoi
Description
The Tower of Hanoi is used to measure capacity on problem solving and planning, self-consciousness and control.
Time Frame
Eighteen week
Title
Tower of Hanoi
Description
The Tower of Hanoi is used to measure capacity on problem solving and planning, self-consciousness and control.
Time Frame
Twenty six week
Title
Cubes Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
First week
Title
Cubes Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Ten week
Title
Cubes Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Eighteen week
Title
Cubes Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Twenty six week
Title
Matrices Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
First week
Title
Matrices Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Ten week
Title
Matrices Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Eighteen week
Title
Matrices Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Twenty six week
Title
Visual Puzzle Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
First week
Title
Visual Puzzle Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Ten week
Title
Visual Puzzle Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Eighteen week
Title
Visual Puzzle Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Twenty six week
Title
Similiraties Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
First week
Title
Similiraties Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Ten week
Title
Similiraties Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Eighteen week
Title
Similiraties Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Twenty six week
Title
Working Memory Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
First week
Title
Working Memory Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Ten week
Title
Working Memory Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Eighteen week
Title
Working Memory Subtest
Description
Composite score of Weschler Adult Intelligence Scale - fourth edition
Time Frame
Twenty six week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clémence ISAAC, PHD
Organizational Affiliation
URC EPS Ville Evrard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Ville Evrard
City
Neuilly-sur-Marne
ZIP/Postal Code
93330
Country
France
Facility Name
URC Ville Evrard
City
Neuilly-sur-Marne
ZIP/Postal Code
93330
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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NARCIS COGNITIVE FOR COGNITIVE DISORDERS OF SCHIZOPHRENIA
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