Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

Not Applicable

Recruiting

• Conditions: Schizophrenic Disorders
• Interventions: Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder; Other: Recovery-Oriented Therapy

• 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

Arm && Interventions

Group	Intervention	Description
Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]	[Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder	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
[THoR] Recovery-Oriented Therapy	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

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
STORI	Twenty six week	Stage of Recovery Instrument - minimum value = 0 - maximum value = 50
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

Trial Locations

Locations (2)

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

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