Schizophrenia Clinical Trial
— RC2S+Official title:
Preliminary Validation of the RC2S+ Therapy in Schizophrenia
Verified date | August 2022 |
Source | Hôpital le Vinatier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: 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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Aged 18-45 years old - 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: - Substance use disorder (criteria of DSM-5), except for caffeine and tobacco - 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 |
Country | Name | City | State |
---|---|---|---|
France | centre de réhabilitation - Hôpital le Vinatier | Lyon | Rhône |
Lead Sponsor | Collaborator |
---|---|
Hôpital le Vinatier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the HB (Hostility Bias) score | AIHQ (Ambiguous Intentions Hostility Questionnaire) | week 12 | |
Secondary | Change from baseline in social cognitive | ACSO ( Self-Assessment Scale of Social Cognition Disorders) | week 12 | |
Secondary | Change from baseline in episodic verbal learning and memory | CVLT( California Verbal Learning Test), | week 12 | |
Secondary | Change from baseline in visual attention and task switching | TMT( Trial Making Test) | week 12 | |
Secondary | Change from baseline in social functioning | FEFSF (First Episode Social Functioning Scale) | week 12 | |
Secondary | Change from baseline in symptoms at week 12 | PANSS (Positive And Negative Symptoms Scale) | week 12 | |
Secondary | Change from baseline in visuospatial abilities at week 12 | TMT( Trial making Test) | week 12 | |
Secondary | Change from baseline in executive functioning at week 12 | FNART(French National Adult reading Test) | week 12 |
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