RC2S+: Remediation of Social Cognitive Impairments

Hôpital le Vinatier

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: active comparator; Behavioral: RC2S+

Study type: Interventional

Funder types: Other

Identifiers

NCT02976077

2016-A01271-50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

RC2S+

Experimental group

Description:

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

Treatment:

Behavioral: RC2S+

Control therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: active comparator