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Clinical Trials/NCT05813457
NCT05813457
Recruiting
Not Applicable

Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study

Centre Hospitalier Universitaire de Saint Etienne6 sites in 1 country416 target enrollmentJune 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychotic Episode
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
416
Locations
6
Primary Endpoint
Duration of untreated psychosis (DUP)
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

The First-Episode Psychosis (FPE) is a severe disorder that can include delusions, cognitive disorders and suicidal behavior. In the majority of cases (more than 80%) it evolves into schizophrenia. Numerous studies show that the rapidity of the initial management of FPE would reduce the risk of negative evolution and would have a decisive impact on the short and long term prognosis. The rapidity of this management can be measured by the duration of untreated psychosis, or DUP (Duration of Untreated Psychosis), the time interval between the appearance of the first frank psychotic symptoms and the initiation of adequate psychiatric care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP. This intervention consists of an early identification program for FPE, the PRESTO program, specifically targeting 3 determining steps in the reduction of DUP:

  • Informing the general population about psychotic disorders
  • Knowledge of front line actors (APL: general practitioners, school and university medicine, teenager's house, associative networks educators, emergency services, firefighters, etc.) about FPE and its management
  • Articulation between APL and specialized psychiatric care

Detailed Description

The DUP is an easily measurable indicator, closely linked to prognosis and potentially modifiable, which has led to its wide use to guide the development of early identification programs. Great disparities exist across the world, between different countries and even different regions. France is unusually late, with an average DUP of at least 18 months. Several elements may contribute to explain this state in France: absence of a specific care program for FPE in the vast majority of psychiatric centers, significant stigmatization of psychiatric illnesses, the opacity of psychiatric care and of psychiatric care and lack of knowledge of its organization, in particular by the primary care network that receives patients with PEP in the first line. To date, there is no systematic program in France designed to rapidly identify FPE patients and hasten their specialized care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP. In addition, this study will seek to analyze the implementation factors of such an intervention in view of a possible generalization and perpetuation.

Registry
clinicaltrials.gov
Start Date
June 6, 2023
End Date
April 1, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or brief psychotic disorder established according to DMS 5
  • Never having taken neuroleptic treatment for antipsychotic purposes, except for the current episode and for a duration of \< 6 month
  • Oral consent of the patient or, for minors, of his/her parents to participate in the study

Exclusion Criteria

  • Patients already treated and followed for FPE
  • Brief psychotic state not requiring specific management

Outcomes

Primary Outcomes

Duration of untreated psychosis (DUP)

Time Frame: Baseline

Defines the time interval between the onset of the first frank psychotic signs noted by the patient and his or her entourage and treatment in specialized psychiatric care

Secondary Outcomes

  • Number of patients still in care(Week 4)
  • Customer satisfaction(Week 4)
  • Caregiver Burden(Baseline and week 4)
  • Assessment of the context(before the start and after the end of the PRESTO program)
  • Engagement in care(Week 4)
  • treatment adherence(Week 4)
  • therapeutic alliance(Week 4)

Study Sites (6)

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