RC2S+: Remediation of Social Cognitive Impairments

Schizophrenia Clinical Trial

— RC2S+  

Official title:

Preliminary Validation of the RC2S+ Therapy in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976077
• Other study ID #: 2016-A01271-50
• Status: Completed
• Phase: N/A
• Start date: November 29, 2016
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2022
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• RC2S+
new cognitive remediation program
• active comparator
cognitive remediation program

Locations

Country	Name	City	State
France	centre de réhabilitation - Hôpital le Vinatier	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the HB (Hostility Bias) score	AIHQ (Ambiguous Intentions Hostility Questionnaire)	week 12
Secondary	Change from baseline in social cognitive	ACSO ( Self-Assessment Scale of Social Cognition Disorders)	week 12
Secondary	Change from baseline in episodic verbal learning and memory	CVLT( California Verbal Learning Test),	week 12
Secondary	Change from baseline in visual attention and task switching	TMT( Trial Making Test)	week 12
Secondary	Change from baseline in social functioning	FEFSF (First Episode Social Functioning Scale)	week 12
Secondary	Change from baseline in symptoms at week 12	PANSS (Positive And Negative Symptoms Scale)	week 12
Secondary	Change from baseline in visuospatial abilities at week 12	TMT( Trial making Test)	week 12
Secondary	Change from baseline in executive functioning at week 12	FNART(French National Adult reading Test)	week 12