A Study of a Remediation Program of Social Cognition in Schizophrenia (REMEDCOG)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Cognitive Remediation of the Ability to Infer Intention of Others in Schizophrenic Patients - A Controlled, Randomized Trial (Phase IIb)|
- 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). [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
- To measure the extension of improvement to other cognitive functions - specific or non specific - and/or to every day life aptitudes [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
- To evaluate correlations with functional measurements (e.g., magneto-encephalography, cognitive evoked potentials) [transversal study; longitudinal study]. [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Experimental: original cognitive therapy||
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).
|No Intervention: no intervention|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077791
|Centre hospitalier de Versailles. Service de Psychiatrie.|
|Le Chesnay, France, 78157|
|Principal Investigator:||Catherine Bourdet, ph||Assistance Publique - Hôpitaux de Paris|