Clinical trial NCT05813457: Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis
Official title: Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Episode
Keywords: Schizophrenia
Psychiatric centers
psychiatric illnesses
psychiatric care
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 416
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Duration of untreated psychosis (DUP)
timeFrame: Baseline
Secondary outcomes:
measure: Number of patients still in care
timeFrame: Week 4
measure: Engagement in care
timeFrame: Week 4
measure: treatment adherence
timeFrame: Week 4
measure: therapeutic alliance
timeFrame: Week 4
measure: Customer satisfaction
timeFrame: Week 4
measure: Caregiver Burden
timeFrame: Baseline and week 4
measure: Assessment of the context
timeFrame: before the start and after the end of the PRESTO program
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Grenoble
country: France
facility: Chu Grenoble
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nîmes
city: Saint-Étienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Eric FAKRA, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: