A Study of a Remediation Program of Social Cognition in Schizophrenia

Schizophrenia Clinical Trial

— REMEDCOG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01077791
• Other study ID #: P070112
• Secondary ID: 2007-A00916-47
• Status: Terminated
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 57 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
France	Centre hospitalier de Versailles. Service de Psychiatrie.	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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