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A Study of a Remediation Program of Social Cognition in Schizophrenia — REMEDCOG  

Schizophrenia Clinical Trial

Official title:
Cognitive Remediation of the Ability to Infer Intention of Others in Schizophrenic Patients - A Controlled, Randomized Trial (Phase IIb)

Clinical Trial Summary

Theory of mind (ability to infer others' intention, emotion, etc) is known to be altered in patients with schizophrenia and its deficit to be correlated with their decreased social proficiency. We designed a novel cognitive therapy, that makes use of videos, aimed at learning a better use of contextual information to infer others' intentions. The aim of this study is to demonstrate, in schizophrenic patients, a quantitative improvement of their ability to infer intention of others induced by this novel training program. A secondary aim is to measure the cerebral correlates (MEG, PeV) of this social cognitive function and of its anticipated improvement.

Clinical Trial Description

Scientific justification : Improvement by training has been demonstrated in Schizophrenic patients for various cognitive functions and skills, though not yet for the social cognition ability specifically dedicated to infer others' intention when not explicit. Main hypothesis : Abilities to infer other's intention can improve in schizophrenic patients following specific practice. Primary aim : To demonstrate this improvement, as quantified by improvement of V-SIR scores (V-LIS scores in French literature). Procedure : Ten weekly sessions of a novel cognitive therapy that makes use of videos aimed at learning a better use of contextual information to infer others' intentions. Group of 5 patients trained by 2 therapists. Comparison with a non-cognitive psycho-educational training (same organisational design). Study design : Controlled randomized simple blind study (equivalent to a Phase IIb therapeutic trial). Matched pair design. 40 patients (20 per arm). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01077791
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Terminated
Phase Phase 2
Start date July 2008
Completion date September 2010
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