A Study of a Remediation Program of Social Cognition in Schizophrenia (REMEDCOG)
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
original cognitive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, social cognition, theory of mind, cognitive therapy, therapeutic trial, magnetoencephalography (MEG)
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
Sites / Locations
- Centre hospitalier de Versailles. Service de Psychiatrie.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
original cognitive therapy
no intervention
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
To measure the extension of improvement to other cognitive functions - specific or non specific - and/or to every day life aptitudes
To evaluate correlations with functional measurements (e.g., magneto-encephalography, cognitive evoked potentials) [transversal study; longitudinal study].
Full Information
NCT ID
NCT01077791
First Posted
February 26, 2010
Last Updated
September 27, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01077791
Brief Title
A Study of a Remediation Program of Social Cognition in Schizophrenia
Acronym
REMEDCOG
Official Title
Cognitive Remediation of the Ability to Infer Intention of Others in Schizophrenic Patients - A Controlled, Randomized Trial (Phase IIb)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Why Stopped
no reponse of the of the treatment
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, social cognition, theory of mind, cognitive therapy, therapeutic trial, magnetoencephalography (MEG)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
original cognitive therapy
Arm Type
Experimental
Arm Title
no intervention
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
original cognitive therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To evaluate correlations with functional measurements (e.g., magneto-encephalography, cognitive evoked potentials) [transversal study; longitudinal study].
Time Frame
6 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Bourdet, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de Versailles. Service de Psychiatrie.
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
12. IPD Sharing Statement
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A Study of a Remediation Program of Social Cognition in Schizophrenia
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