Schizophrenia
Conditions
Keywords
social cognition, cognitive remediation, emotions, theory of mind, attributions, social perception
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRC2S+
new cognitive remediation program
BEHAVIORALactive comparator
cognitive remediation program
Sponsors
Hôpital le Vinatier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the HB (Hostility Bias) score | week 12 | AIHQ (Ambiguous Intentions Hostility Questionnaire) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in social cognitive | week 12 | ACSO ( Self-Assessment Scale of Social Cognition Disorders) |
| Change from baseline in episodic verbal learning and memory | week 12 | CVLT( California Verbal Learning Test), |
| Change from baseline in visual attention and task switching | week 12 | TMT( Trial Making Test) |
| Change from baseline in social functioning | week 12 | FEFSF (First Episode Social Functioning Scale) |
| Change from baseline in symptoms at week 12 | week 12 | PANSS (Positive And Negative Symptoms Scale) |
| Change from baseline in visuospatial abilities at week 12 | week 12 | TMT( Trial making Test) |
| Change from baseline in executive functioning at week 12 | week 12 | FNART(French National Adult reading Test) |
Countries
France
Outcome results
None listed