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Clinical Trials/NCT04608032
NCT04608032
Recruiting
N/A

Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

Centre hospitalier de Ville-Evrard, France2 sites in 1 country70 target enrollmentSeptember 8, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenic Disorders
Sponsor
Centre hospitalier de Ville-Evrard, France
Enrollment
70
Locations
2
Primary Endpoint
STROOP
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2020
End Date
December 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre hospitalier de Ville-Evrard, France
Responsible Party
Principal Investigator
Principal Investigator

Clémence ISAAC

Principal Investigator

Centre hospitalier de Ville-Evrard, France

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

Outcomes

Primary Outcomes

STROOP

Time Frame: pre-inclusion

Interference score

TMTB

Time Frame: pre-inclusion

Trail Making Test

Litteral score of Verbal fluences

Time Frame: pre-inclusion

Litteral score of Verbal fluences

GO/NOGO

Time Frame: pre-inclusion

cognitive control score

tower of Hanoi

Time Frame: pre-inclusion

Tower planning total score from tower of Hanoi

Matrix test (WAIS-IV)

Time Frame: pre-inclusion

The perceptual reasoning score of the Matrix test.

Secondary Outcomes

  • PANSS(pre-inclusion)
  • ERF(Twenty six week)
  • ERF-CS(Twenty six week)
  • QFS(Twenty six week)
  • Mini-500(pre-inclusion)
  • CTQ(pre-inclusion)
  • EESEP(Twenty six week)
  • MCQ-30(Twenty six week)
  • SAIQ(Twenty six week)
  • SCS(Twenty six week)
  • SDS(Twenty six week)
  • STORI(Twenty six week)

Study Sites (2)

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