RC2S+: Remediation of Social Cognitive Impairments (RC2S+)
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|ClinicalTrials.gov Identifier: NCT02976077|
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : February 9, 2021
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|
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
To treat social cognitive impairments in people with schizophrenia.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preliminary Validation of the RC2S+ Therapy in Schizophrenia|
|Actual Study Start Date :||November 29, 2016|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Preparation sessions (sessions 1 & 2):
Cognitive remediation (sessions 3 to 22):
Transfer sessions (sessions 23 & 24):
new cognitive remediation program
Active Comparator: Control therapy
Preparation sessions (sessions 1 & 2):
Cognitive remediation (sessions 3 to 24):
Behavioral: active comparator
cognitive remediation program
- Change from baseline in the HB (Hostility Bias) score [ Time Frame: week 12 ]AIHQ (Ambiguous Intentions Hostility Questionnaire)
- Change from baseline in social cognitive [ Time Frame: week 12 ]ACSO ( Self-Assessment Scale of Social Cognition Disorders)
- Change from baseline in episodic verbal learning and memory [ Time Frame: week 12 ]CVLT( California Verbal Learning Test),
- Change from baseline in visual attention and task switching [ Time Frame: week 12 ]TMT( Trial Making Test)
- Change from baseline in social functioning [ Time Frame: week 12 ]FEFSF (First Episode Social Functioning Scale)
- Change from baseline in symptoms at week 12 [ Time Frame: week 12 ]PANSS (Positive And Negative Symptoms Scale)
- Change from baseline in visuospatial abilities at week 12 [ Time Frame: week 12 ]TMT( Trial making Test)
- Change from baseline in executive functioning at week 12 [ Time Frame: week 12 ]FNART(French National Adult reading Test)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976077
|Contact: FRANCK NICOLAS, PUPH||0033 (0)4 26 73 85 31||Nicolas.firstname.lastname@example.org|
|Contact: PEYROUX ELODIE, DR||0033 (0)4 26 73 85 email@example.com|
|centre de réhabilitation - Hôpital le Vinatier||Recruiting|
|Lyon, Rhône, France, 69006|
|Contact: Franck Nicolas, PUPH +33 (0)4 26 23 76 11 firstname.lastname@example.org|
|Contact: Gaudelus Baptiste +33 (0)4 26 23 76 11 email@example.com|
|Principal Investigator: Franck Nicolas|
|Principal Investigator:||FRANCK NICOLAS, PUPH||LE VINATIER HOSPITAL BRON FRANCE|