Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia (NARCIS)

Centre hospitalier de Ville-Evrard, France

Status: Enrolling

Conditions: Schizophrenic Disorders

Treatments: Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder; Other: Recovery-Oriented Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04608032

10477M-NARCIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

[THoR] Recovery-Oriented Therapy

Active Comparator group

Description:

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

Treatment:

Other: Recovery-Oriented Therapy