A Study of a Remediation Program of Social Cognition in Schizophrenia

NCT01077791 | Terminated Phase 2

• 2 other identifiers: P0701122007-A00916-47
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To measure the extension of improvement to other cognitive functions - specific or non specific - and/or to every day life aptitudes

  6 MONTHS

• To evaluate correlations with functional measurements (e.g., magneto-encephalography, cognitive evoked potentials) [transversal study; longitudinal study].

  6 MONTHS

Study Arms (2)

original cognitive therapy

EXPERIMENTAL

Behavioral: original cognitive therapy

no intervention

NO INTERVENTION

Interventions

original cognitive therapy 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).

original cognitive therapy

Eligibility Criteria

• Age: 18 Years - 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any other organic or neuropsychiatric disease

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre hospitalier de Versailles. Service de Psychiatrie.

Le Chesnay, 78157, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Catherine Bourdet, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 1, 2010
• Study Start: July 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 28, 2021

Record last verified: 2010-10

Locations

FR (1)