A Study of a Remediation Program of Social Cognition in Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: original cognitive therapy


Participation Criteria
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Eligibility Criteria
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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: Any other organic or neuropsychiatric disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: original cognitive therapy<br> | Behavioral: original cognitive therapy<br>* 12 weekly sequences of an original cognitive therapy based on videos involving the learning of a better use of contextual information to infer others' intention. Group of 5 patients trained by 2 therapeutics. Comparison with a non-cognitive psychoeducational training (same organisational design).<br>|
| No Intervention: no intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate a measurable improvement of Theory of Mind based ability in schizophrenic patients induced by a novel cognitive therapy, as quantified by improvement of V-SIR scores (V-LIS scores in French literature). |  | 6 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the extension of improvement to other cognitive functions - specific or non specific - and/or to every day life aptitudes |  | 6 MONTHS | 
| To evaluate correlations with functional measurements (e.g., magneto-encephalography, cognitive evoked potentials) [transversal study; longitudinal study]. |  | 6 MONTHS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, social cognition, theory of mind, cognitive therapy, therapeutic trial, magnetoencephalography (MEG)