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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT02976077
First received: November 16, 2016
Last updated: January 17, 2017
Last verified: January 2017
  Purpose

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 Intervention
Schizophrenia Behavioral: RC2S+ Behavioral: active comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preliminary Validation of the RC2S+ Therapy in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Hôpital le Vinatier:

Primary Outcome Measures:
  • Change from baseline in the HB (Hostility Bias) score [ Time Frame: week 12 ]
    AIHQ (Ambiguous Intentions Hostility Questionnaire)


Secondary Outcome Measures:
  • 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)


Enrollment: 58
Study Start Date: December 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02976077

Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Principal Investigator: FRANCK NICOLAS, PUPH LE VINATIER HOSPITAL BRON FRANCE
  More Information

Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02976077     History of Changes
Other Study ID Numbers: 2016-A01271-50
Study First Received: November 16, 2016
Last Updated: January 17, 2017

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

ClinicalTrials.gov processed this record on July 27, 2017