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

NCT ID: NCT02667834

Last Updated: 2019-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Social Cognition and Interaction Training (SCIT)

SCIT Social cognition and interaction training program.

Group Type EXPERIMENTAL

Social Cognition and Interaction Training (SCIT)

Intervention Type BEHAVIORAL

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

Therapeutic education program (ETP)

Therapeutic education program

Group Type ACTIVE_COMPARATOR

therapeutic education program (ETP)

Intervention Type BEHAVIORAL

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

Interventions

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Social Cognition and Interaction Training (SCIT)

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

Intervention Type BEHAVIORAL

therapeutic education program (ETP)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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FRANCK NICOLAS, PUPH

Role: PRINCIPAL_INVESTIGATOR

CH LE VINATIER

Locations

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Centre Hospitalier de Clermont de l'Oise

Clermont, OISE, France

Site Status

Countries

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France

Other Identifiers

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2014-A00072-45

Identifier Type: -

Identifier Source: org_study_id

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