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

Sponsor

Hôpital le Vinatier (Other)

Overall Status

Completed

CT.gov ID

NCT02667834

Collaborator

(none)

103

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: Social Cognition and Interaction Training (SCIT) Behavioral: therapeutic education program (ETP)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier de Clermont de l'Oise	Clermont	Oise	France	60607

Sponsors and Collaborators

Hôpital le Vinatier

Investigators

Principal Investigator: FRANCK NICOLAS, PUPH, CH LE VINATIER

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hôpital le Vinatier

ClinicalTrials.gov Identifier:

NCT02667834

Other Study ID Numbers:

2014-A00072-45

First Posted:

Jan 29, 2016

Last Update Posted:

Oct 30, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Hôpital le Vinatier

social cognition

cognitive remediation

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Oct 30, 2019