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Completed

NCT Number: NCT02976077

RC2S+: Remediation of Social Cognitive Impairments

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, 69006, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RC2S+

Behavioral

new cognitive remediation program

Active comparator

Behavioral

cognitive remediation program

Primary outcomes

  1. Change from baseline in the HB (Hostility Bias) score

    Time frame: week 12

    AIHQ (Ambiguous Intentions Hostility Questionnaire)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Preliminary Validation of the RC2S+ Therapy in Schizophrenia

Acronym: RC2S+

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2016
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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