NCT02976077

RC2S+: Remediation of Social Cognitive Impairments

Preliminary Validation of the RC2S+ Therapy in Schizophrenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	RC2S+	new cognitive remediation program
BEHAVIORAL	active comparator	cognitive remediation program

Timeline

• Start date: 2016-11-29
• Primary completion: 2021-06-30
• Completion: 2021-12-30
• First posted: 2016-11-29
• Last updated: 2022-08-12

Locations

1 site across 1 country: France