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A Study of a Remediation Program of Social Cognition in Schizophrenia

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01077791
Acronym
REMEDCOG
Enrollment
26
Registered
2010-03-01
Start date
2008-07-31
Completion date
2010-09-30
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, social cognition, theory of mind, cognitive therapy, therapeutic trial, magnetoencephalography (MEG)

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).

Interventions

BEHAVIORALoriginal 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).

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 57 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To measure the extension of improvement to other cognitive functions - specific or non specific - and/or to every day life aptitudes6 MONTHS
To evaluate correlations with functional measurements (e.g., magneto-encephalography, cognitive evoked potentials) [transversal study; longitudinal study].6 MONTHS

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026