Prospective Cohort Study of a Population at Risk of Psychotic Transition

NCT06539611 | Active Not Recruiting DMC

• 1 other identifier: 2024-A00720-47
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

At-risk Mental States

Keywords

at-risk mental states; early intervention; psychotic transition; subjective cognitive complaint

Outcome Measures

Primary Outcomes (1)

• Percent of Psychotic transition in UHR

  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)

  30 months

Secondary Outcomes (9)

• Assessment of complaints versus absence of complaints in UHRs

  3 months

• Assessment of attentional impairment versus absence of attentional impairment in UHRs with cognitive complaint

  3 months

• Date of psychotic transition in UHR patients

  30 months

• Clinical factors associated with transition in UHR: insight scale BCIS

  at baseline: day 1

• Clinical factors associated with transition in UHR: self -esteem.

  at baseline: day 1

Interventions

Observational OTHER

This study is observationnal: Questionnaires to assess the endpoint

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Have already presented a First Psychotic Episode;
• Previous diagnosis of schizophrenia, psychotic disorder or bipolar disorder;
• Known intellectual disability ;
• Pregnant or breast-feeding woman;
• Minors and adults under legal protection.

Sponsors & Collaborators

• Centre Hospitalier Esquirol: lead

Study Sites (1)

Mirvat B HAMDAN-DUMONT

Limoges, 87025, France

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Mirvat B HAMDAN-DUMONT, MD

  Hospital Esquirol Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 66 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: November 18, 2024
• Primary Completion: November 18, 2024
• Study Completion (Estimated): March 1, 2030
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)