Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia (NARCIS)

This study evaluates the effect of a cognitive remediation program on neurocognitive, social cognitive and metacognitive functions designed for patients living with a schizophrenia spectrum disorder.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenic Disorders
• Intervention / Treatment: Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder; Other: Recovery-Oriented Therapy

Detailed Description

Evaluation of the specific therapeutic efficacy of the ecological cognitive remediation program for schizophrenia spectrum disorder [ECo-Sz] on neurocognitive deficits, social cognition deficits and metacognition deficits of patients with a schizophrenia spectrum disorder.

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique JANUEL, MBBS; Phone Number: 0143093232; Email: d.januel@epsve.fr

Study Locations

• France
  • Neuilly-sur-Marne, France, 93330
    • Recruiting
    • Ch Ville Evrard
    • Contact: Clémence Isaac, MSC; Phone Number: 0143093232; Email: clm.isaac@gmail.com
    • Principal Investigator: Clémence ISAAC, MBBS
  • Neuilly-sur-Marne, France, 93330
    • Recruiting
    • URC Ville Evrard
    • Contact: Clémence ISAAC, PHD; Phone Number: 0143093232; Email: clm.isaac@gmail.com
    • Contact: Youcef BENCHERIF, CRA; Phone Number: 0143093232; Email: y.bencherif@epsve.fr
    • Principal Investigator: Clémence ISAAC, PHD
    • Sub-Investigator: Alex MOTUT, MSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]; 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; The first group will have [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder; Other Names: [Eco-Sz]
Active Comparator: [THoR] Recovery-Oriented Therapy; 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; The second group will have [THoR] Recovery-Oriented Therapy; Other Names: [THoR]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STROOP	Interference score	pre-inclusion
TMTB	Trail Making Test	pre-inclusion
Litteral score of Verbal fluences	Litteral score of Verbal fluences	pre-inclusion
GO/NOGO	cognitive control score	pre-inclusion
tower of Hanoi	Tower planning total score from tower of Hanoi	pre-inclusion
Matrix test (WAIS-IV)	The perceptual reasoning score of the Matrix test.	pre-inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-500	(Entretien structuré Neuropsychiatrique International	pre-inclusion
CTQ	Childhood Trauma Questionnaire - minimum value = 28 - maximum value = 112	pre-inclusion
PANSS	Positive and Negative Syndrome Scale - minimum value = 30 - maximum value = 210	pre-inclusion
EESEP	Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105	Eighteen week
EESEP	Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105	Twenty six week
ERF	Functional Impact Scale - minimum value = 5 - maximum value = 35	First week
ERF	Functional Impact Scale - minimum value = 5 - maximum value = 35	Ten week
ERF	Functional Impact Scale - minimum value = 5 - maximum value = 35	Eighteen week
ERF	Functional Impact Scale - minimum value = 5 - maximum value = 35	Twenty six week
ERF-CS	Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20	First week
ERF-CS	Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20	Ten week
ERF-CS	Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20	Eighteen week
ERF-CS	Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20	Twenty six week
MCQ-30	Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120	First week
MCQ-30	Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120	Ten week
MCQ-30	Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120	Eighteen week
MCQ-30	Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120	Twenty six week
QFS	Social Functioning Questionnaire - no minimum or maximum value	First week
QFS	Social Functioning Questionnaire - no minimum or maximum value	Ten week
QFS	Social Functioning Questionnaire - no minimum or maximum value	Eighteen week
QFS	Social Functioning Questionnaire - no minimum or maximum value	Twenty six week
SAIQ	Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68	First week
SAIQ	Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68	Ten week
SAIQ	Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68	Eighteen week
SAIQ	Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68	Twenty six week
SCS	Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66	First week
SCS	Revised Self-Consciousness Scale- minimum value = 0 - maximum value = 66	Ten week
SCS	Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66	Eighteen week
SCS	Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66	Twenty six week
SDS	Social Desirability Scale - minimum value = 0 - maximum value = 33	First week
SDS	Social Desirability Scale - minimum value = 0 - maximum value = 33	Ten week
SDS	Social Desirability Scale - minimum value = 0 - maximum value = 33	Eighteen week
SDS	Social Desirability Scale - minimum value = 0 - maximum value = 33	Twenty six week
STORI	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50	First week
STORI	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50	Ten week
STORI	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50	Eighteen week
STORI	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50	Twenty six week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEM IV Logical Memory	Composite score of the Weschler Memory Scale - fourth edition	First week
FAUX-PAS Test	A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60	First week
FAUX-PAS Test	A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60	Ten week week
FAUX-PAS Test	A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60	Eighteen week week
FAUX-PAS Test	A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60	Twenty six week
The Rey/Taylor complex figure test	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 - minimum value = 0 - maximum value = 36	First week
The Rey/Taylor complex figure test	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 - minimum value = 0 - maximum value = 36	Ten week
The Rey/Taylor complex figure test	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 - minimum value = 0 - maximum value = 36	Eighteen week
The Rey/Taylor complex figure test	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 - minimum value = 0 - maximum value = 36	Twenty six week
MEM IV Logical Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
MEM IV Logical Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
MEM IV Logical Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
MEM IV Symbol Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
MEM IV Symbol Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
MEM IV Symbol Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
MEM IV Symbol Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
The Balloon Analogue Risk Task	The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value	First week
The Balloon Analogue Risk Task	The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value	Ten week
The Balloon Analogue Risk Task	The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value	Eighteen week
The Balloon Analogue Risk Task	The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value	Twenty six week
D2 Test	The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value	First week
D2 Test	The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value	Ten week
D2 Test	The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value	Eighteen week
D2 Test	The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value	Twenty six week
ToM-15	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 - no minimum or maximum value	First week
ToM-15	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 - no minimum or maximum value	Ten week
ToM-15	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 - no minimum or maximum value	Eighteen week
ToM-15	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 - no minimum or maximum value	Twenty six week
Cubes Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Cubes Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Cubes Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Cubes Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Visual Puzzle Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Visual Puzzle Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Visual Puzzle Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Visual Puzzle Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Similiraties Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Similiraties Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Similiraties Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Similiraties Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Working Memory Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Working Memory Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Working Memory Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Working Memory Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week

Collaborators and Investigators

• Sponsor: Centre hospitalier de Ville-Evrard, France
• Investigators: Principal Investigator: Clémence ISAAC, PHD, URC EPS Ville Evrard

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognitive remediation; Neurocognition; Metacognition; Social cognition
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Cognition Disorders; Schizophrenia; Cognitive Dysfunction
• Other Study ID Numbers: 10477M-NARCIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No