RC2S+: Remediation of Social Cognitive Impairments

Study Overview
=================
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: To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive processes To assess the impact of the RC2S+ therapy versus control therapy on social functioning To assess the impact of the RC2S+ therapy versus control therapy on both positive and negative symptoms To study the maintenance of benefits 3 months forward Outcomes: To treat social cognitive impairments in people with schizophrenia.

Official Title
-----------------
Preliminary Validation of the RC2S+ Therapy in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: RC2S+
* Behavioral: active comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RC2S+<br>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 | Behavioral: RC2S+<br>* new cognitive remediation program<br>|
| Active Comparator: Control therapy<br>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 | Behavioral: active comparator<br>* cognitive remediation program<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the HB (Hostility Bias) score | AIHQ (Ambiguous Intentions Hostility Questionnaire) | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in social cognitive | ACSO ( Self-Assessment Scale of Social Cognition Disorders) | week 12 | 
| Change from baseline in episodic verbal learning and memory | CVLT( California Verbal Learning Test), | week 12 | 
| Change from baseline in visual attention and task switching | TMT( Trial Making Test) | week 12 | 
| Change from baseline in social functioning | FEFSF (First Episode Social Functioning Scale) | week 12 | 
| Change from baseline in symptoms at week 12 | PANSS (Positive And Negative Symptoms Scale) | week 12 | 
| Change from baseline in visuospatial abilities at week 12 | TMT( Trial making Test) | week 12 | 
| Change from baseline in executive functioning at week 12 | FNART(French National Adult reading Test) | week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
social cognition, cognitive remediation, emotions, theory of mind, attributions, social perception