Clinical trial NCT02667834: Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program
Official title: Efficiency of the French Translation Program:Social Cognition and Interactive Training (SCIT) of Negative Symptoms in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: social cognition
cognitive remediation
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in Scale of Assessment of Negative Symptoms
timeFrame: 40 weeks
Secondary outcomes:
measure: Change from baseline in positive and negative symptoms scale (PANSS)
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Clermont
country: France
facility: Centre Hospitalier de Clermont de l'Oise
state: Oise
Study officials:
affiliation: CH LE VINATIER
name: FRANCK NICOLAS, PUPH
role: PRINCIPAL_INVESTIGATOR
References: