Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-11-29
2021-12-30
Brief Summary
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Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life.
New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes.
The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.
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Detailed Description
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This is a randomized controlled trial to establish the validity of the RC2S+ program in schizophrenia.
The project's main objective is to assess the impact of RC2S+ on social cognitive impairments in schizophrenia compared with a cognitive remediation program (control therapy) focusing on neurocognition, equivalent in terms of number, duration and rhythm of sessions.
The study has four other objectives:
1. To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive processes
2. To assess the impact of the RC2S+ therapy versus control therapy on social functioning
3. To assess the impact of the RC2S+ therapy versus control therapy on both positive and negative symptoms
4. To study the maintenance of benefits 3 months forward
Outcomes:
To treat social cognitive impairments in people with schizophrenia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RC2S+
RC2S+
Preparation sessions (sessions 1 \& 2):
* Functional Outcomes Scale - Social Cognition (ERF-CS)
* Psychoeducation about social cognitive impairments
* Concrete objectives
Cognitive remediation (sessions 3 to 22):
* Paper-and-pencil session
* Simulation session
* Home-based task
Transfer sessions (sessions 23 \& 24):
* Transfer of skills in dayly life - generalization
* Assessment of the achievement of objectives
RC2S+
new cognitive remediation program
Control therapy
Control therapy
Preparation sessions (sessions 1 \& 2):
* Functional Outcomes Scale - Neurocognition
* Psychoeducation about cognitive impairments
* Concrete objectives
Cognitive remediation (sessions 3 to 24):
* Paper-and-pencil session
* Simulation session
* Home-based task
active comparator
cognitive remediation program
Interventions
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RC2S+
new cognitive remediation program
active comparator
cognitive remediation program
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of schizophrenia assessed with DSM5 criteria (APA, 2013)
* No modification of psychotropic treatment during the month before inclusion (variation of 20% of the dose is tolerated
* French native language or education in a French school since the first year of primary school
* Consent to participate to the study and agreement of the legal guardian
* Patients who have not benefited from cognitive remediation during the three months before inclusion
Exclusion Criteria
* Neurologic disorders (vascular, infectious or neurodegenerative)
* Uncorrected visual deficit
* Medical drugs with cerebral or psychological effect (e.g, corticosteroids)
* Patients resistant to antipsychotic medication
* Pregnancy
18 Years
45 Years
ALL
No
Sponsors
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Hôpital le Vinatier
OTHER
Responsible Party
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Principal Investigators
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FRANCK NICOLAS, PUPH
Role: PRINCIPAL_INVESTIGATOR
LE VINATIER HOSPITAL BRON FRANCE
Locations
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centre de réhabilitation - Hôpital le Vinatier
Lyon, Rhône, France
Countries
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Other Identifiers
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2016-A01271-50
Identifier Type: -
Identifier Source: org_study_id
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