Pilot Study of a New Insight Assessment Tool
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
patients with schizophrenia and their designated relatives
Evaluation of the patient's insight (an inclusion phase, followed by two evaluation phases on D0 and D7) by the patient, his / her close and two caregivers (inter-judicial fidelity)
干预措施: Assessment of the insight of schizophrenic patients by themselves, their relatives and caregivers (Other)
结局指标
主要结局
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)
时间窗: 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)
次要结局
- 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)