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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Social Cognition and Interaction Training (SCIT); Behavioral: therapeutic education program (ETP)

• Registration Number: NCT02667834
• Lead Sponsor: Hôpital le Vinatier

Brief 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Primary Completion: 2019-09-30
• Status Verified: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Cognition and Interaction Training (SCIT)	Social Cognition and Interaction Training (SCIT)	SCIT Social cognition and interaction training program.
Therapeutic education program (ETP)	therapeutic education program (ETP)	Therapeutic education program

Primary Outcome Measures

Name	Time	Method
Change from baseline in Scale of Assessment of Negative Symptoms	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 Outcome Measures

Name	Time	Method
Change from baseline in positive and negative symptoms scale (PANSS)	40 weeks	Scales for clinical and psychosocial functioning measurement

Trial Locations

Locations (1)

Centre Hospitalier de Clermont de l'Oise; 🇫🇷 Clermont, Oise, France