Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

Not Applicable

Recruiting

• Conditions: Schizophrenic Disorders

• Registration Number: NCT04608032
• Lead Sponsor: Centre hospitalier de Ville-Evrard, France

Brief 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.

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 Timeline

• Study Start: 2020-09-08
• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Ch Ville Evrard; 🇫🇷 Neuilly-sur-Marne, France

URC Ville Evrard; 🇫🇷 Neuilly-sur-Marne, France