Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

Schizophrenic Disorders Clinical Trial

— NARCIS  

Official title:

Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608032
• Other study ID #: 10477M-NARCIS
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Dominique JANUEL, MBBS
• Phone: 0143093232
• Email: d.januel[@]epsve.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Schizophrenia
• Schizophrenic Disorders

Intervention

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
• Recovery-Oriented Therapy
The second group will have [THoR] Recovery-Oriented Therapy

Locations

Country	Name	City	State
France	Ch Ville Evrard	Neuilly-sur-Marne
France	URC Ville Evrard	Neuilly-sur-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	MEM IV Logical Memory	Composite score of the Weschler Memory Scale - fourth edition	First week
Other	MEM IV Logical Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Other	MEM IV Logical Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Other	MEM IV Logical Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Other	MEM IV Symbol Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Other	MEM IV Symbol Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Other	MEM IV Symbol Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Other	MEM IV Symbol Memory	Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Other	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
Other	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
Other	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
Other	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
Other	D2 Test	The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value	First week
Other	D2 Test	The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value	Ten week
Other	D2 Test	The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value	Eighteen week
Other	D2 Test	The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value	Twenty six week
Other	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
Other	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
Other	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
Other	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
Other	Cubes Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Other	Cubes Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Other	Cubes Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Other	Cubes Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Other	Visual Puzzle Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Other	Visual Puzzle Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Other	Visual Puzzle Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Other	Visual Puzzle Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Other	Similiraties Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Other	Similiraties Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Other	Similiraties Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Other	Similiraties Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Other	Working Memory Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	First week
Other	Working Memory Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Ten week
Other	Working Memory Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Eighteen week
Other	Working Memory Subtest	Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20	Twenty six week
Primary	STROOP	Interference score	pre-inclusion
Primary	TMTB	Trail Making Test	pre-inclusion
Primary	Litteral score of Verbal fluences	Litteral score of Verbal fluences	pre-inclusion
Primary	GO/NOGO	cognitive control score	pre-inclusion
Primary	tower of Hanoi	Tower planning total score from tower of Hanoi	pre-inclusion
Primary	Matrix test (WAIS-IV)	The perceptual reasoning score of the Matrix test.	pre-inclusion
Secondary	Mini-500	(Entretien structuré Neuropsychiatrique International	pre-inclusion
Secondary	CTQ	Childhood Trauma Questionnaire - minimum value = 28 - maximum value = 112	pre-inclusion
Secondary	PANSS	Positive and Negative Syndrome Scale - minimum value = 30 - maximum value = 210	pre-inclusion
Secondary	EESEP	Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105	Eighteen week
Secondary	EESEP	Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105	Twenty six week
Secondary	ERF	Functional Impact Scale - minimum value = 5 - maximum value = 35	First week
Secondary	ERF	Functional Impact Scale - minimum value = 5 - maximum value = 35	Ten week
Secondary	ERF	Functional Impact Scale - minimum value = 5 - maximum value = 35	Eighteen week
Secondary	ERF	Functional Impact Scale - minimum value = 5 - maximum value = 35	Twenty six week
Secondary	ERF-CS	Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20	First week
Secondary	ERF-CS	Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20	Ten week
Secondary	ERF-CS	Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20	Eighteen week
Secondary	ERF-CS	Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20	Twenty six week
Secondary	MCQ-30	Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120	First week
Secondary	MCQ-30	Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120	Ten week
Secondary	MCQ-30	Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120	Eighteen week
Secondary	MCQ-30	Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120	Twenty six week
Secondary	QFS	Social Functioning Questionnaire - no minimum or maximum value	First week
Secondary	QFS	Social Functioning Questionnaire - no minimum or maximum value	Ten week
Secondary	QFS	Social Functioning Questionnaire - no minimum or maximum value	Eighteen week
Secondary	QFS	Social Functioning Questionnaire - no minimum or maximum value	Twenty six week
Secondary	SAIQ	Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68	First week
Secondary	SAIQ	Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68	Ten week
Secondary	SAIQ	Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68	Eighteen week
Secondary	SAIQ	Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68	Twenty six week
Secondary	SCS	Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66	First week
Secondary	SCS	Revised Self-Consciousness Scale- minimum value = 0 - maximum value = 66	Ten week
Secondary	SCS	Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66	Eighteen week
Secondary	SCS	Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66	Twenty six week
Secondary	SDS	Social Desirability Scale - minimum value = 0 - maximum value = 33	First week
Secondary	SDS	Social Desirability Scale - minimum value = 0 - maximum value = 33	Ten week
Secondary	SDS	Social Desirability Scale - minimum value = 0 - maximum value = 33	Eighteen week
Secondary	SDS	Social Desirability Scale - minimum value = 0 - maximum value = 33	Twenty six week
Secondary	STORI	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50	First week
Secondary	STORI	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50	Ten week
Secondary	STORI	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50	Eighteen week
Secondary	STORI	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50	Twenty six week