Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis

NCT ID: NCT05813457

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2027-04-30

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.

Conditions

Psychotic Episode

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PRESTO program

The PRESTO programs consists of an early identification program for First Episod Psychosis, called PRESTO (First Episodes Raise Awareness Treat Referral), including 3 complementary components:

• Information campaign for the general population
• Training of front-line actors
• Facilitating access to specialized care by setting up mobile teams made up of "pivotal" workers who provide the link between front-line actors and specialized psychiatric care

Group Type: EXPERIMENTAL

PRESTO Early Identification Program

Intervention Type: OTHER

The program combines :

1. A population-based information component (information campaign aimed at the general population).

2. A training component for the LPAs (Front Line Actors: general practitioners, school and university medicine, pharmacists, teenagers school and university medicine, pharmacists, teenagers' homes, association networks, SAMU, firemen, etc.).

3. Facilitated access to care for FPE patients in the form of a "pivot" mobile team that can directly meet the patient at the request of the LPA, initiate care and ensure the relay within a the relay within 4 weeks to the existing specialized psychiatric structures on the site (CMP, CATTP (CMP, CATTP, day hospital, hospitalization unit, child and adolescent psychiatry services) adolescent psychiatry services)

Usual Care

No change in the conditions of referral of First Episod Psychosis (emergencies, hospitalizations, consultations)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PRESTO Early Identification Program

The program combines :

1. A population-based information component (information campaign aimed at the general population).

2. A training component for the LPAs (Front Line Actors: general practitioners, school and university medicine, pharmacists, teenagers school and university medicine, pharmacists, teenagers' homes, association networks, SAMU, firemen, etc.).

3. Facilitated access to care for FPE patients in the form of a "pivot" mobile team that can directly meet the patient at the request of the LPA, initiate care and ensure the relay within a the relay within 4 weeks to the existing specialized psychiatric structures on the site (CMP, CATTP (CMP, CATTP, day hospital, hospitalization unit, child and adolescent psychiatry services) adolescent psychiatry services)

Intervention Type: OTHER

Other Intervention Names

PRESTO Program

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric FAKRA, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Hospices Civils de Lyon

Bron, , France

Site Status: RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Chu Grenoble

Grenoble, , France

Site Status: RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status: RECRUITING

CHU de Nîmes

Nîmes, , France

Site Status: RECRUITING

Chu Saint Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eric FAKRA, MD PhD

Role: CONTACT

eric.fakra@chu-st-etienne.fr

(0)477127885 ext. +33

Amandine BAUDOT, CRA

Role: CONTACT

amandine.baudot@chu-st-etienne.fr

(0)477829450 ext. +33

Facility Contacts

MD

Role: primary

Eric FAKRA, MD PhD

Role: primary

Other Identifiers

2021-A00787-34

Identifier Type: OTHER

Identifier Source: secondary_id

19PH228

Identifier Type: -

Identifier Source: org_study_id