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Clinical Trials/NCT03071939
NCT03071939
Withdrawn
Not Applicable

Pilot Study of a New Insight Assessment Tool

Hôpital le Vinatier1 site in 1 countryJanuary 2, 2018
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Hôpital le Vinatier
Locations
1
Primary Endpoint
Concurrent validity of the hetero-evaluation scale by studying its correlation with the results obtained, for the same persons, on the SUMD scale (Scale to Assess Unawareness of Mental Disorder)
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief Summary

Schizophrenia is a disease of young adults that affects 1% of the general population. According to numerous studies, it has been estimated that between 50% and 80% of patients with schizophrenia do not consider to have a mental disorder and are therefore not aware of their disorders. A poor degree of insight is associated with poor compliance, a higher number of re-hospitalizations, altered social and relational functioning, and a higher number of suicides and violent behaviors. This is why insight, which is an essential dimension of psychopathology, must be evaluated, as it depends to a large extent on the therapeutic alliance, adherence to treatment, likelihood of relapse and prognosis.

Detailed Description

Evaluation (test, re-test) This new tool for assessing insight will allow for a discrepancy in assessment and a more refined assessment with a view to developing specific care for the patient and / or the relative with regard to the three dimensions Evaluated: disease, treatment and functional implications

Registry
clinicaltrials.gov
Start Date
January 2, 2018
End Date
April 2, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hôpital le Vinatier
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of schizophrenia
  • Age from 18 to 50 years old
  • Stabilized clinical condition (without therapeutic modification during the month prior to inclusion)
  • French language read, spoken and understood (patient and family member)
  • Having given his consent
  • Agreement of the guardian for persons under guardianship
  • Consent of the relative

Exclusion Criteria

  • Refusal of patient or legal guardian
  • Refusal of the loved one
  • Patient and / or neurological disorder of neurological origin of vascular, infectious or neurodegenerative origin

Outcomes

Primary Outcomes

Concurrent validity of the hetero-evaluation scale by studying its correlation with the results obtained, for the same persons, on the SUMD scale (Scale to Assess Unawareness of Mental Disorder)

Time Frame: two years

Correlation higher than 0.40 in the Bravais-Pearson test between the caregiver's hetero-evaluation scale and the Scale to Assess Understanding of Mental Disorder (SUMD)

Secondary Outcomes

  • Cronbach's alpha coefficient with a value of 0.7 measuring internal consistency(two years)
  • Correlation greater than 0.40 at the Bravais-Pearson test measuring test fidelity, re-testing(two years)
  • Correlation greater than 0.40 to inter-judge fidelity to Cohen's Kappa test(two years)

Study Sites (1)

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