Clinical trial NCT01077791: A Study of a Remediation Program of Social Cognition in Schizophrenia
Official title: Cognitive Remediation of the Ability to Infer Intention of Others in Schizophrenic Patients - A Controlled, Randomized Trial (Phase IIb)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
social cognition
theory of mind
cognitive therapy
therapeutic trial
magnetoencephalography (MEG)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-03-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 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).
timeFrame: 6 MONTHS
Secondary outcomes:
measure: To measure the extension of improvement to other cognitive functions - specific or non specific - and/or to every day life aptitudes
timeFrame: 6 MONTHS
measure: To evaluate correlations with functional measurements (e.g., magneto-encephalography, cognitive evoked potentials) [transversal study; longitudinal study].
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Centre hospitalier de Versailles. Service de Psychiatrie.
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Catherine Bourdet, MD
role: PRINCIPAL_INVESTIGATOR
References: