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Completed

NCT Number: NCT02667834

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Clermont de l'Oise

Clermont, OISE, 60607, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Social cognition and interaction training (SCIT)

Behavioral

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

therapeutic education program (ETP)

Behavioral

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

Primary outcomes

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

    Time frame: 40 weeks

    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

Secondary outcomes

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

    Time frame: 40 weeks

    Scales for clinical and psychosocial functioning measurement

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Efficiency of the French Translation Program:Social Cognition and Interactive Training (SCIT) of Negative Symptoms in Schizophrenia

Acronym: SCIT-VF

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2016
Registry last updated
Oct 30, 2019

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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