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CompletedNCT02667834SCIT-VFUpdated Oct 30, 2019

Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program

An interventional study of Social Cognition and Interaction Training (SCIT) and therapeutic education program (ETP) in Schizophrenia, sponsored by Hôpital le Vinatier. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-10-30.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2014, registered Jan 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study summary

Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual (ETP) in helping people with schizophrenia improve their social cognition and social functioning so specially on negative symptoms. Many studies show a connection between negative symptom and social cognition in schizophrenia.

Read the detailed description

This is a multicenter (6 centers in France), randomized, controlled trial compared people aged 18 to 50 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manual of Mental disorders, 4th edition (DSM-IV-TR), the Social Cognition and Interaction Training (SCIT) program will be compared to an already validated neurocognitive remediation program : therapeutic education program (ETP) Social Cognition and Interaction Training (SCIT) is composed of three phases: emotion training, figuring out situations, and integration. Social Cognition and Interaction Training (SCIT) will be delivered by therapists in 20 weekly sessions over 5 months.

160 patients will be randomized as follows: - Arm1, experimental: Social Cognition and Interaction Training (SCIT): 30h with therapist, videos and photos exercises - Arm 2, control: therapeutic education program (ETP): 30h with therapist, only discussion between patients.

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Conditions studied

  • Schizophrenia

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Keywords

  • social cognition
  • cognitive remediation
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 103 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women aged 18 to 50 years old
  • Diagnosis of schizophrenia according to the DSM-IV-TR
  • French speaker
  • Unchanged psychotropic treatment during month preceding the inclusion
  • Patients having given their consent lit to participate in the study
  • Patients not having been part of therapeutic education program during six months preceding the inclusion
  • Affiliated to the French social security

Exclusion criteria

Exclusion Criteria:

  • Alcohol or drug dependence(according to the DSM-IV-TR),except Tobacco
  • History of neurobiological illness or trauma
  • Taking of medicine with somatic aim having a cerebral or psychic impact (ex: corticosteroids)
  • Simultaneous participation on another program of cognitive remediation
  • The ineffectiveness of neuroleptic treatment
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Social Cognition and Interaction Training (SCIT)

    SCIT Social cognition and interaction training program.

    Behavioral: Social Cognition and Interaction Training (SCIT)

  • Active comparator
    Therapeutic education program (ETP)

    Therapeutic education program

    Behavioral: therapeutic education program (ETP)

Interventions

  • BehavioralSocial Cognition and Interaction Training (SCIT)

    A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders

  • Behavioraltherapeutic education program (ETP)

    usual treatment ,30 hours with therapist, only discussion between patients

06

What researchers measure

Primary outcomes

  1. Change from baseline in Scale of Assessment of Negative Symptoms

    Improvement of negative symptoms of schizophrenia in patients who received Social Cognition and Interaction Training (SCIT) program compared to patients receiving a Therapeutic Education Program (ETP), equivalent in number, duration and rhythm of sessions

    Time frame: 40 weeks

Secondary outcomes

  1. Change from baseline in positive and negative symptoms scale (PANSS)

    Scales for clinical and psychosocial functioning measurement

    Time frame: 40 weeks

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Study locations

1 site
  • Centre Hospitalier de Clermont de l'Oise
    Clermont, Oise 60607, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02667834
Lead sponsor
Hôpital le Vinatier
Responsible party
Sponsor
First posted
Jan 29, 2016
Start date
Oct 2014
Primary completion
Sep 30, 2019
Completion
Oct 2019
Last update
Oct 30, 2019

Study contacts

FRANCK NICOLAS, PUPH
principal investigator · CH LE VINATIER

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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