Clinical trial NCT04608032: Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia
Official title: Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenic Disorders
Keywords: Schizophrenia
Neurocognition
Social cognition
Metacognition
Cognitive remediation
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: STROOP
timeFrame: pre-inclusion
measure: TMTB
timeFrame: pre-inclusion
measure: Litteral score of Verbal fluences
timeFrame: pre-inclusion
measure: GO/NOGO
timeFrame: pre-inclusion
measure: tower of Hanoi
timeFrame: pre-inclusion
measure: Matrix test (WAIS-IV)
timeFrame: pre-inclusion
Secondary outcomes:
measure: Mini-500
timeFrame: pre-inclusion
measure: CTQ
timeFrame: pre-inclusion
measure: PANSS
timeFrame: pre-inclusion
measure: EESEP
timeFrame: Eighteen week
measure: EESEP
timeFrame: Twenty six week
measure: ERF
timeFrame: First week
measure: ERF
timeFrame: Ten week
measure: ERF
timeFrame: Eighteen week
measure: ERF
timeFrame: Twenty six week
measure: ERF-CS
timeFrame: First week
measure: ERF-CS
timeFrame: Ten week
measure: ERF-CS
timeFrame: Eighteen week
measure: ERF-CS
timeFrame: Twenty six week
measure: MCQ-30
timeFrame: First week
measure: MCQ-30
timeFrame: Ten week
measure: MCQ-30
timeFrame: Eighteen week
measure: MCQ-30
timeFrame: Twenty six week
measure: QFS
timeFrame: First week
measure: QFS
timeFrame: Ten week
measure: QFS
timeFrame: Eighteen week
measure: QFS
timeFrame: Twenty six week
measure: SAIQ
timeFrame: First week
measure: SAIQ
timeFrame: Ten week
measure: SAIQ
timeFrame: Eighteen week
measure: SAIQ
timeFrame: Twenty six week
measure: SCS
timeFrame: First week
measure: SCS
timeFrame: Ten week
measure: SCS
timeFrame: Eighteen week
measure: SCS
timeFrame: Twenty six week
measure: SDS
timeFrame: First week
measure: SDS
timeFrame: Ten week
measure: SDS
timeFrame: Eighteen week
measure: SDS
timeFrame: Twenty six week
measure: STORI
timeFrame: First week
measure: STORI
timeFrame: Ten week
measure: STORI
timeFrame: Eighteen week
measure: STORI
timeFrame: Twenty six week
Other outcomes:
measure: FAUX-PAS Test
timeFrame: First week
measure: FAUX-PAS Test
timeFrame: Ten week week
measure: FAUX-PAS Test
timeFrame: Eighteen week week
measure: FAUX-PAS Test
timeFrame: Twenty six week
measure: The Rey/Taylor complex figure test
timeFrame: First week
measure: The Rey/Taylor complex figure test
timeFrame: Ten week
measure: The Rey/Taylor complex figure test
timeFrame: Eighteen week
measure: The Rey/Taylor complex figure test
timeFrame: Twenty six week
measure: MEM IV Logical Memory
timeFrame: First week
measure: MEM IV Logical Memory
timeFrame: Ten week
measure: MEM IV Logical Memory
timeFrame: Eighteen week
measure: MEM IV Logical Memory
timeFrame: Twenty six week
measure: MEM IV Symbol Memory
timeFrame: First week
measure: MEM IV Symbol Memory
timeFrame: Ten week
measure: MEM IV Symbol Memory
timeFrame: Eighteen week
measure: MEM IV Symbol Memory
timeFrame: Twenty six week
measure: The Balloon Analogue Risk Task
timeFrame: First week
measure: The Balloon Analogue Risk Task
timeFrame: Ten week
measure: The Balloon Analogue Risk Task
timeFrame: Eighteen week
measure: The Balloon Analogue Risk Task
timeFrame: Twenty six week
measure: D2 Test
timeFrame: First week
measure: D2 Test
timeFrame: Ten week
measure: D2 Test
timeFrame: Eighteen week
measure: D2 Test
timeFrame: Twenty six week
measure: ToM-15
timeFrame: First week
measure: ToM-15
timeFrame: Ten week
measure: ToM-15
timeFrame: Eighteen week
measure: ToM-15
timeFrame: Twenty six week
measure: Cubes Subtest
timeFrame: First week
measure: Cubes Subtest
timeFrame: Ten week
measure: Cubes Subtest
timeFrame: Eighteen week
measure: Cubes Subtest
timeFrame: Twenty six week
measure: Visual Puzzle Subtest
timeFrame: First week
measure: Visual Puzzle Subtest
timeFrame: Ten week
measure: Visual Puzzle Subtest
timeFrame: Eighteen week
measure: Visual Puzzle Subtest
timeFrame: Twenty six week
measure: Similiraties Subtest
timeFrame: First week
measure: Similiraties Subtest
timeFrame: Ten week
measure: Similiraties Subtest
timeFrame: Eighteen week
measure: Similiraties Subtest
timeFrame: Twenty six week
measure: Working Memory Subtest
timeFrame: First week
measure: Working Memory Subtest
timeFrame: Ten week
measure: Working Memory Subtest
timeFrame: Eighteen week
measure: Working Memory Subtest
timeFrame: Twenty six week
Locations:
city: Neuilly-sur-Marne
country: France
facility: Ch Ville Evrard
city: Neuilly-sur-Marne
country: France
facility: URC Ville Evrard
Study officials:
affiliation: URC EPS Ville Evrard
name: Clémence ISAAC, PHD
role: PRINCIPAL_INVESTIGATOR
References: