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

Psychotic Episode Clinical Trial

— PRESTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813457
• Other study ID #: 19PH228
• Secondary ID: 2021-A00787-34
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: April 2027

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Eric FAKRA, MD PhD
• Phone: (0)477127885
• Email: eric.fakra[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 416
• Est. completion date: April 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Psychotic Episode

Intervention

Other:
• PRESTO Early Identification Program
The program combines : A population-based information component (information campaign aimed at the general population). 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.). 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)

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron
France	Chu Clermont-Ferrand	Clermont-Ferrand
France	Chu Grenoble	Grenoble
France	CHU de Montpellier	Montpellier
France	CHU de Nîmes	Nîmes
France	Chu Saint Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of untreated psychosis (DUP)	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	Baseline
Secondary	Number of patients still in care	measurement of the number of patients continuing care	Week 4
Secondary	Engagement in care	Measurement of engagement in care through the Service Engagement Scale. It is a 14-item questionnaire, scored from 0 to 3, divided into four categories: availability, cooperation, help-seeking attitude and therapeutic adherence. The questionnaire is completed by the clinician.	Week 4
Secondary	treatment adherence	Medication Adherence Rating Scale (MARS) is a 10-item self-reporting multidimensional instrument describing three dimensions: medication adherence behavior (items 1-4), attitude toward taking medication (items 5-8) and negative side effects and attitudes to psychotropic medication (items 9-10). The total score ranges from 0-10 with a higher score indicating better adherence.	Week 4
Secondary	therapeutic alliance	measurement of the therapeutic alliance with the "Working Alliance Inventory" self-questionnaire given to the patient and the clinician. It is a self-administered questionnaire with a 36-item therapist or caregiver component and a 36-item patient component. Each item is rated from 1 to 7 (never to always). The score range is 36 to 252. Higher score reflect a more positive rating of working alliance.	Week 4
Secondary	Customer satisfaction	Measurement of Customer satisfaction by self-questionnaire with 8 items applicable to a population with psychotic disorders. The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction.	Week 4
Secondary	Caregiver Burden	Measurement of Caregiver Burden by the Zarit Burden Interview in Caregivers of Patients is a self-questionnaire given to the caregiver. This questionnaire consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0 to 88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.	Baseline and week 4
Secondary	Assessment of the context	Semi-structured interview wera done with stakeholders of PRESTO program to assess contextual factors that increase or limit the effect of the intervention, integration of the intervention into the care organization scheme, collaboration with inpatient, outpatient and non-healthcare sectors, means identified to sustain the intervention.	before the start and after the end of the PRESTO program