Clinical trial NCT06539611: Prospective Cohort Study of a Population at Risk of Psychotic Transition
Official title: Prospective Cohort Study of a Population at Risk of Psychotic Transition
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: At-risk Mental States
Keywords: at-risk mental states
early intervention
psychotic transition
subjective cognitive complaint
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 125
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All youth help-seekers assessed by early intervention team meeting the inclusion criteria will be asked to participate to the study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percent of Psychotic transition in UHR
timeFrame: 30 months
Secondary outcomes:
measure: Assessment of complaints versus absence of complaints in UHRs
timeFrame: 3 months
measure: Assessment of attentional impairment versus absence of attentional impairment in UHRs with cognitive complaint
timeFrame: 3 months
measure: Date of psychotic transition in UHR patients
timeFrame: 30 months
measure: Clinical factors associated with transition in UHR: insight scale BCIS
timeFrame: at baseline: day 1
measure: Clinical factors associated with transition in UHR: self -esteem.
timeFrame: at baseline: day 1
measure: Clinical factors associated with transition in UHR: depression
timeFrame: at baseline: day 1
measure: Difference between three groups (NoP no psychosis, UHR and FEP first episode psychosis): insight scale
timeFrame: at baseline: day 1
measure: Difference between three groups (NoP, UHR and FEP): self-esteem.
timeFrame: at baseline: day 1
measure: Difference between three groups ((NoP, UHR and FEP): depression.
timeFrame: at baseline: day 1
Other outcomes:
Locations:
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