A Study of a Remediation Program of Social Cognition in Schizophrenia

Phase 2

Terminated

• Conditions: Schizophrenia
• Interventions: Behavioral: original cognitive therapy

• Registration Number: NCT01077791
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-10
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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.

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Exclusion Criteria

• Any other organic or neuropsychiatric disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
original cognitive therapy	original cognitive therapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre hospitalier de Versailles. Service de Psychiatrie.; 🇫🇷 Le Chesnay, France