Prospective Cohort Study of a Population at Risk of Psychotic Transition
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Percent of Psychotic transition in UHR
研究概览
简要总结
In psychiatry, insight is the patient's awareness of his or her disorder or symptom. Lack of insight also seems to be associated with the presence of anxiety-depressive symptoms.
There are several forms of insight:
- clinical" insight, which is the perception of suffering from a given pathology or symptoms
- cognitive insight (CI), which is the ability to analyse or judge one's own thoughts, beliefs and judgements
- and the insight of cognitive disorders or the subjective perception of the cognitive alterations (or cognitive symptoms) presented. In this study, the investigators will refer to this dimension as 'subjective cognitive complaint' (SCP), in order to differentiate it from cognitive insight, the name of which may lead to confusion.
In schizophrenic disorders, there is a positive correlation between the subjective cognitive complaint SCC, and certain alterations in the neurocognitive assessment, including the attentional dimension. There are scales for collecting SCC in psychotic disorders, such as the SSTICS. To date, there is no scale validated specifically for the UHR population. Thus, the scales used (STICSS, SCoRS, etc.) are validated in populations presenting a characterised psychotic state. Objective impairment is measured during a neurocognitive assessment carried out by a specialised professional: a clinical psychologist specialised in neuropsychology. The cognitive performance of UHR patients is impaired, particularly in terms of cognitive flexibility and self-perception of cognitive disorders, and there may be a discrepancy between the complaint, the objective disorders and their identification as "disorders" by the patient.
Despite this discrepancy, to the investigators knowledge no study to date has investigated a possible link between SCC and psychotic transition in this population. Thus, it is not known whether social class may be a factor in exposure to transition, or whether there is a link at all between social class and risk of transition. The aim of this study is to determine psychotic transition in UHR in a 30 months follow-up, and to determine whether there is a link between SCC and transition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ;
- •Be aged between 15 and 30 ;
- •Being assessed by the eDIP (early intervention team "équipe de détection et d'intervention précoce") ;
- •Sufficient level of French to understand and express yourself orally and in writing;
- •For adults:
- •Patients who have received informed information about the study and who have signed a consent to participate in the study;
- •- For minors: Patient who has received informed information about the study and who has signed, as well as the holders of parental authority the minor's consent to participate in the study.
排除标准
- •Have already presented a First Psychotic Episode;
- •Previous diagnosis of schizophrenia, psychotic disorder or bipolar disorder;
- •Being on antipsychotic treatment at the time of inclusion ;
- •Known intellectual disability ;
- •Pregnant or breast-feeding woman;
- •Minors and adults under legal protection.
结局指标
主要结局
Percent of Psychotic transition in UHR
时间窗: 30 months
Use of the CAARMS scale The section on positive symptoms uses a score of symptom intensity (out of 6 points) and frequency (out of 6 points) to determine whether the patient has reached a threshold of mild psychosis (UHR)
次要结局
- Assessment of complaints versus absence of complaints in UHRs(3 months)
- Date of psychotic transition in UHR patients(30 months)
- Clinical factors associated with transition in UHR: self -esteem.(at baseline: day 1)
- Clinical factors associated with transition in UHR: insight scale BCIS(at baseline: day 1)
- Difference between three groups (NoP no psychosis, UHR and FEP first episode psychosis): insight scale(at baseline: day 1)
- Difference between three groups (NoP, UHR and FEP): self-esteem.(at baseline: day 1)
- Assessment of attentional impairment versus absence of attentional impairment in UHRs with cognitive complaint(3 months)
- Clinical factors associated with transition in UHR: depression(at baseline: day 1)
- Difference between three groups ((NoP, UHR and FEP): depression.(at baseline: day 1)
研究者
Dr Mirvat HAMDAN-DUMONT
Principal investigator
Centre Hospitalier Esquirol