A Study of a Remediation Program of Social Cognition in Schizophrenia (REMEDCOG)

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 2

Conditions

Schizophrenia

Treatments

Behavioral: original cognitive therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01077791

2007-A00916-47 (Registry Identifier)

P070112

Details and patient eligibility

About

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.

Full 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).

Enrollment

26 patients

Sex

All

Ages

18 to 57 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Schizophrenia following DSM IV;
Age 18-57;
Stability of the clinical state;
Ability to learn;
Deficit in intention reading as measure with the V-SIR (V-LIS in French) test (score >13);
informed consent to participate to the study.

Exclusion criteria