RC2S+: Remediation of Social Cognitive Impairments (RC2S+)
Preliminary Validation of the RC2S+ Therapy in Schizophrenia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive processes
- To assess the impact of the RC2S+ therapy versus control therapy on social functioning
- To assess the impact of the RC2S+ therapy versus control therapy on both positive and negative symptoms
- To study the maintenance of benefits 3 months forward
Outcomes:
To treat social cognitive impairments in people with schizophrenia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhône
-
Lyon, Rhône, France, 69006
- centre de réhabilitation - Hôpital le Vinatier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: RC2S+
RC2S+ Preparation sessions (sessions 1 & 2):
Cognitive remediation (sessions 3 to 22):
Transfer sessions (sessions 23 & 24):
|
new cognitive remediation program
|
|
ACTIVE_COMPARATOR: Control therapy
Control therapy Preparation sessions (sessions 1 & 2):
Cognitive remediation (sessions 3 to 24):
|
cognitive remediation program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in the HB (Hostility Bias) score
Time Frame: week 12
|
AIHQ (Ambiguous Intentions Hostility Questionnaire)
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in symptoms at week 12
Time Frame: week 12
|
PANSS (Positive And Negative Symptoms Scale)
|
week 12
|
|
Change from baseline in social cognitive
Time Frame: week 12
|
ACSO ( Self-Assessment Scale of Social Cognition Disorders)
|
week 12
|
|
Change from baseline in episodic verbal learning and memory
Time Frame: week 12
|
CVLT( California Verbal Learning Test),
|
week 12
|
|
Change from baseline in visual attention and task switching
Time Frame: week 12
|
TMT( Trial Making Test)
|
week 12
|
|
Change from baseline in social functioning
Time Frame: week 12
|
FEFSF (First Episode Social Functioning Scale)
|
week 12
|
|
Change from baseline in visuospatial abilities at week 12
Time Frame: week 12
|
TMT( Trial making Test)
|
week 12
|
|
Change from baseline in executive functioning at week 12
Time Frame: week 12
|
FNART(French National Adult reading Test)
|
week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: FRANCK NICOLAS, PUPH, LE VINATIER HOSPITAL BRON FRANCE
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-A01271-50
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