Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program (SCIT-VF)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Social Cognition and Interaction Training (SCIT)
therapeutic education program (ETP)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring social cognition, cognitive remediation
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier de Clermont de l'Oise
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Social Cognition and Interaction Training (SCIT)
Therapeutic education program (ETP)
Arm Description
SCIT Social cognition and interaction training program.
Therapeutic education program
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from baseline in positive and negative symptoms scale (PANSS)
Scales for clinical and psychosocial functioning measurement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02667834
Brief Title
Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program
Acronym
SCIT-VF
Official Title
Efficiency of the French Translation Program:Social Cognition and Interactive Training (SCIT) of Negative Symptoms in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
social cognition, cognitive remediation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Cognition and Interaction Training (SCIT)
Arm Type
Experimental
Arm Description
SCIT Social cognition and interaction training program.
Arm Title
Therapeutic education program (ETP)
Arm Type
Active Comparator
Arm Description
Therapeutic education program
Intervention Type
Behavioral
Intervention Name(s)
Social Cognition and Interaction Training (SCIT)
Intervention Description
A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders
Intervention Type
Behavioral
Intervention Name(s)
therapeutic education program (ETP)
Intervention Description
usual treatment ,30 hours with therapist, only discussion between patients
Primary Outcome Measure Information:
Title
Change from baseline in Scale of Assessment of Negative Symptoms
Description
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
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in positive and negative symptoms scale (PANSS)
Description
Scales for clinical and psychosocial functioning measurement
Time Frame
40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCK NICOLAS, PUPH
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Clermont de l'Oise
City
Clermont
State/Province
Oise
ZIP/Postal Code
60607
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program
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