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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Social Cognition and Interaction Training (SCIT); Behavioral: therapeutic education program (ETP)

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Oise
    • Clermont, Oise, France, 60607
      • Centre Hospitalier de Clermont de l'Oise

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Cognition and Interaction Training (SCIT); SCIT Social cognition and interaction training program.	Behavioral: Social Cognition and Interaction Training (SCIT); A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders
Active Comparator: Therapeutic education program (ETP); Therapeutic education program	Behavioral: therapeutic education program (ETP); usual treatment ,30 hours with therapist, only discussion between patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in positive and negative symptoms scale (PANSS)	Scales for clinical and psychosocial functioning measurement	40 weeks

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: FRANCK NICOLAS, PUPH, CH Le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: social cognition; cognitive remediation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 2014-A00072-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No