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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Psychotic Episode

Treatments

Other: PRESTO Early Identification Program

Study type

Interventional

Funder types

Other

Identifiers

NCT05813457
19PH228
2021-A00787-34 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

416 estimated patients

Sex

All

Ages

15 to 35 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

416 participants in 2 patient groups

PRESTO program
Experimental group
Description:
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
Treatment:
Other: PRESTO Early Identification Program
Usual Care
No Intervention group
Description:
No change in the conditions of referral of First Episod Psychosis (emergencies, hospitalizations, consultations)

Trial contacts and locations

6

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Central trial contact

Amandine BAUDOT, CRA; Eric FAKRA, MD PhD

Data sourced from clinicaltrials.gov

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