Cognitive Remediation Therapy and Schizophrenia

Hôpital le Vinatier77 enrolled

Overview

Objectives: The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with schizophrenia.

Methods: In a 2 arms blind study versus sham,80 patients with schizophrenia were enrolled in a program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software. Measures of cognitive functioning using the Cogtest® battery as well as social autonomy (Social Autonomy Scale, EAS) and schizophrenia symptoms (Positive And Negative Syndrome Scale, PANSS) were undertaken at the beginning and the end of the meetings of remediation. Among those 80 participants, 30 patients to (15 active / 15 sham) were randomized to participate in an fMRI study in order to investigate the impact of such CRT program on brain functioning (n-back task before CRT and 3 months later).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Schizophrenia

Interventions

cognitive remediation therapyBEHAVIORAL

program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software

non-CRTBEHAVIORAL

waiting list

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * schizophrenia (DSM IV criteria) * remitted symptoms * french language * informed consent Exclusion Criteria: * addiction, neurological disease * only for second randomized patient participating in MRI study (n=30) : MRI counterindications

Locations (1)

Hôpital le vinatier

Bron, France

Outcomes

Primary Outcomes

cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)

standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).

Time frame: before and after CRT (3 months later)

Secondary Outcomes

brain functioning (fMRI)

fMRI during a n-back task, 2 times, before CRT and 3 months later. The 2 sub-groups of 15 patients will be compared with healthy subjects performances at the same task.

Time frame: before and after CRT (3 months later)

schizophrenia symptoms

standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)

Time frame: before CRT and 3 months later

Data from ClinicalTrials.gov

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