Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

NCT04608032 | Recruiting

• 1 other identifier: 10477M-NARCIS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenic Disorders

Keywords

Schizophrenia; Neurocognition; Social cognition; Metacognition; Cognitive remediation

Outcome Measures

Primary Outcomes (6)

• STROOP

  Interference score

  pre-inclusion

• TMTB

  Trail Making Test

  pre-inclusion

• Litteral score of Verbal fluences

  Litteral score of Verbal fluences

  pre-inclusion

• GO/NOGO

  cognitive control score

  pre-inclusion

• tower of Hanoi

  Tower planning total score from tower of Hanoi

  pre-inclusion

• Matrix test (WAIS-IV)

  The perceptual reasoning score of the Matrix test.

  pre-inclusion

Secondary Outcomes (37)

• Mini-500

  pre-inclusion

• CTQ

  pre-inclusion

• PANSS

  pre-inclusion

• EESEP

  Eighteen week

• EESEP

  Twenty six week

Other Outcomes (44)

• FAUX-PAS Test

  First week

• FAUX-PAS Test

  Ten week week

• FAUX-PAS Test

  Eighteen week week

Study Arms (2)

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

EXPERIMENTAL

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

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

[THoR] Recovery-Oriented Therapy

ACTIVE COMPARATOR

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

Other: Recovery-Oriented Therapy

Interventions

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

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

Also known as: [Eco-Sz]

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

Recovery-Oriented Therapy OTHER

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

Also known as: [THoR]

[THoR] Recovery-Oriented Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (2)

Ch Ville Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

URC Ville Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Thor protein, Drosophila

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Clémence ISAAC, PHD

  URC EPS Ville Evrard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique JANUEL, MBBS

CONTACT

0143093232; d.januel@epsve.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: September 8, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)