Cognitive Remediation Therapy and Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: non-CRT; Behavioral: cognitive remediation therapy

• Registration Number: NCT01078129
• Lead Sponsor: Hôpital le Vinatier

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2006-01
• Primary Completion: 2008-03
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Study Completion: 2010-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-CRT	non-CRT	no intervention
behavior therapy - CRT	cognitive remediation therapy	behavior program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions) by means REHACOM® software

Primary Outcome Measures

Name	Time	Method
cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)	before and after CRT (3 months later)	standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).

Secondary Outcome Measures

Name	Time	Method
brain functioning (fMRI)	before and after CRT (3 months later)	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.
schizophrenia symptoms	before CRT and 3 months later	standardised psychometric scale measuring Positive an Negative Symptoms (PANSS)

Trial Locations

Locations (1)

Hôpital le vinatier; 🇫🇷 Bron, France