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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RC2S+
active comparator
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring social cognition, cognitive remediation, emotions, theory of mind, attributions, social perception

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • centre de réhabilitation - Hôpital le Vinatier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RC2S+

Control therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in the HB (Hostility Bias) score
AIHQ (Ambiguous Intentions Hostility Questionnaire)

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2016
Last Updated
August 11, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT02976077
Brief Title
RC2S+: Remediation of Social Cognitive Impairments
Acronym
RC2S+
Official Title
Preliminary Validation of the RC2S+ Therapy in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
social cognition, cognitive remediation, emotions, theory of mind, attributions, social perception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RC2S+
Arm Type
Experimental
Arm Description
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
Arm Title
Control therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
RC2S+
Intervention Description
new cognitive remediation program
Intervention Type
Behavioral
Intervention Name(s)
active comparator
Intervention Description
cognitive remediation program
Primary Outcome Measure Information:
Title
Change from baseline in the HB (Hostility Bias) score
Description
AIHQ (Ambiguous Intentions Hostility Questionnaire)
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Change from baseline in social cognitive
Description
ACSO ( Self-Assessment Scale of Social Cognition Disorders)
Time Frame
week 12
Title
Change from baseline in episodic verbal learning and memory
Description
CVLT( California Verbal Learning Test),
Time Frame
week 12
Title
Change from baseline in visual attention and task switching
Description
TMT( Trial Making Test)
Time Frame
week 12
Title
Change from baseline in social functioning
Description
FEFSF (First Episode Social Functioning Scale)
Time Frame
week 12
Title
Change from baseline in symptoms at week 12
Description
PANSS (Positive And Negative Symptoms Scale)
Time Frame
week 12
Title
Change from baseline in visuospatial abilities at week 12
Description
TMT( Trial making Test)
Time Frame
week 12
Title
Change from baseline in executive functioning at week 12
Description
FNART(French National Adult reading Test)
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCK NICOLAS, PUPH
Organizational Affiliation
LE VINATIER HOSPITAL BRON FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
centre de réhabilitation - Hôpital le Vinatier
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69006
Country
France

12. IPD Sharing Statement

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RC2S+: Remediation of Social Cognitive Impairments

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