Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

NCT ID: NCT04608032

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Schizophrenic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]

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

Group Type EXPERIMENTAL

[Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder

Intervention Type OTHER

The first group will have \[Eco-Sz\] Ecological Cognitive training program for schizophrenia spectrum disorder

[THoR] 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

Group Type ACTIVE_COMPARATOR

Recovery-Oriented Therapy

Intervention Type OTHER

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

Interventions

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[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

Intervention Type OTHER

Recovery-Oriented Therapy

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

Intervention Type OTHER

Other Intervention Names

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[Eco-Sz] [THoR]

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de Ville-Evrard, France

OTHER

Sponsor Role lead

Responsible Party

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Clémence ISAAC

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clémence ISAAC, PHD

Role: PRINCIPAL_INVESTIGATOR

URC EPS Ville Evrard

Locations

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Ch Ville Evrard

Neuilly-sur-Marne, , France

Site Status RECRUITING

URC Ville Evrard

Neuilly-sur-Marne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique JANUEL, MBBS

Role: CONTACT

0143093232

Facility Contacts

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Clémence Isaac, MSC

Role: primary

0143093232

Clémence ISAAC, PHD

Role: primary

0143093232

Youcef BENCHERIF, CRA

Role: backup

0143093232

Other Identifiers

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10477M-NARCIS

Identifier Type: -

Identifier Source: org_study_id

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