A Study of a Remediation Program of Social Cognition in Schizophrenia

NCT ID: NCT01077791

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-09-30

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).

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

original cognitive therapy

Group Type: EXPERIMENTAL

original cognitive therapy

Intervention Type: BEHAVIORAL

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).

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

original cognitive therapy

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 57 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Bourdet, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Centre hospitalier de Versailles. Service de Psychiatrie.

Le Chesnay, , France

Countries

France

Other Identifiers

2007-A00916-47

Identifier Type: REGISTRY

Identifier Source: secondary_id

P070112

Identifier Type: -

Identifier Source: org_study_id