NCT02667834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

5 years

First QC Date

January 19, 2016

Last Update Submit

October 29, 2019

Conditions

Schizophrenia

Keywords

social cognitioncognitive remediation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline in positive and negative symptoms scale (PANSS)

    40 weeks

Study Arms (2)

Social Cognition and Interaction Training (SCIT)

EXPERIMENTAL

SCIT Social cognition and interaction training program.

Behavioral: Social Cognition and Interaction Training (SCIT)

Therapeutic education program (ETP)

ACTIVE COMPARATOR

Therapeutic education program

Behavioral: therapeutic education program (ETP)

Interventions

Social Cognition and Interaction Training (SCIT)BEHAVIORAL

A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders

Social Cognition and Interaction Training (SCIT)
therapeutic education program (ETP)BEHAVIORAL

usual treatment ,30 hours with therapist, only discussion between patients

Therapeutic education program (ETP)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18 to 50 years old
  • Diagnosis of schizophrenia according to the DSM-IV-TR
  • French speaker
  • Patients having given their consent lit to participate in the study
  • Affiliated to the French social security

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Clermont de l'Oise

Clermont, OISE, 60607, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • FRANCK NICOLAS, PUPH

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 29, 2016

Study Start

October 1, 2014

Primary Completion

September 30, 2019

Study Completion

October 1, 2019

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)