RC2S+: Remediation of Social Cognitive Impairments

NCT02976077 | Completed

• 1 other identifier: 2016-A01271-50
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

social cognition; cognitive remediation; emotions; theory of mind; attributions; social perception

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the HB (Hostility Bias) score

  AIHQ (Ambiguous Intentions Hostility Questionnaire)

  week 12

Secondary Outcomes (7)

• Change from baseline in social cognitive

  week 12

• Change from baseline in episodic verbal learning and memory

  week 12

• Change from baseline in visual attention and task switching

  week 12

• Change from baseline in social functioning

  week 12

• Change from baseline in symptoms at week 12

  week 12

Study Arms (2)

RC2S+

EXPERIMENTAL

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+

Control therapy

ACTIVE COMPARATOR

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

Interventions

RC2S+ BEHAVIORAL

new cognitive remediation program

RC2S+

active comparator BEHAVIORAL

cognitive remediation program

Control therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-45 years old
• Diagnosis of schizophrenia assessed with DSM5 criteria (APA, 2013)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, 69006, France

Location

Related Publications (1)

• Peyroux E, Prost Z, Amado I, Graux J, Demily C, Plasse J, Franck N; RC2S Consortium. Is the Cognitive Remediation of Social Cognition (RC2S) program useful to improve social cognition and functional outcomes in people with schizophrenia? A randomized controlled trial. Psychiatr Rehabil J. 2026 Jan 12. doi: 10.1037/prj0000673. Online ahead of print.

  PMID: 41525374 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• FRANCK NICOLAS, PUPH

  LE VINATIER HOSPITAL BRON FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 29, 2016
• Study Start: November 29, 2016
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

FR (1)