Cognitive Remediation Therapy and Schizophrenia

Hôpital le Vinatier

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: non-CRT; Behavioral: cognitive remediation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01078129

2005-094B

Details and patient eligibility

About

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.

Full 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).

Enrollment: 77 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 2 patient groups

behavior therapy - CRT

Active Comparator group

Description:

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

Treatment:

Behavioral: cognitive remediation therapy

non-CRT

Sham Comparator group

Description:

no intervention

Treatment:

Behavioral: non-CRT