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.
Methods: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
new cognitive remediation program
cognitive remediation program
centre de réhabilitation - Hôpital le Vinatier
Lyon, Rhône, France
Change from baseline in the HB (Hostility Bias) score
AIHQ (Ambiguous Intentions Hostility Questionnaire)
Time frame: week 12
Change from baseline in social cognitive
ACSO ( Self-Assessment Scale of Social Cognition Disorders)
Time frame: week 12
Change from baseline in episodic verbal learning and memory
CVLT( California Verbal Learning Test),
Time frame: week 12
Change from baseline in visual attention and task switching
TMT( Trial Making Test)
Time frame: week 12
Change from baseline in social functioning
FEFSF (First Episode Social Functioning Scale)
Time frame: week 12
Change from baseline in symptoms at week 12
PANSS (Positive And Negative Symptoms Scale)
Time frame: week 12
Change from baseline in visuospatial abilities at week 12
TMT( Trial making Test)
Time frame: week 12
Change from baseline in executive functioning at week 12
FNART(French National Adult reading Test)
Time frame: week 12
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