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

Schizophrenia Clinical Trial

— SCIT-VF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667834
• Other study ID #: 2014-A00072-45
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Social Cognition and Interaction Training (SCIT)
A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders
• therapeutic education program (ETP)
usual treatment ,30 hours with therapist, only discussion between patients

Locations

Country	Name	City	State
France	Centre Hospitalier de Clermont de l'Oise	Clermont	Oise

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in positive and negative symptoms scale (PANSS)	Scales for clinical and psychosocial functioning measurement	40 weeks