RC2S+: Remediation of Social Cognitive Impairments (RC2S+)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Behavioral: RC2S+; Behavioral: active comparator	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	58 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Preliminary Validation of the RC2S+ Therapy in Schizophrenia
Study Start Date :	December 2016
Estimated Primary Completion Date :	July 2018
Estimated Study Completion Date :	November 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: RC2S+; 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+; new cognitive remediation program
Active Comparator: Control therapy; 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; cognitive remediation program

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline in the HB (Hostility Bias) score [ Time Frame: week 12 ]
   AIHQ (Ambiguous Intentions Hostility Questionnaire)

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Hôpital le Vinatier

Investigators

Principal Investigator:	FRANCK NICOLAS, PUPH	LE VINATIER HOSPITAL BRON FRANCE

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hôpital le Vinatier
ClinicalTrials.gov Identifier:	NCT02976077 History of Changes
Other Study ID Numbers:	2016-A01271-50
First Posted:	November 29, 2016
Last Update Posted:	February 8, 2018
Last Verified:	February 2018

Keywords provided by Hôpital le Vinatier:

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

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders