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. 2025 May 15;25(1):488.
doi: 10.1186/s12888-025-06940-y.

PEPsy-CM study protocol: impact of a 3-year program for early psychosis based on case-management on relapse rate, a French multicenter randomized trial

Aurélie Schandrin  1 , Julie Jourdan  2 , Sihame Chkair  3 , Sophie Bouvet  3 , Pascale Fabbro-Peray  3 , Mocrane Abbar  2 ; PEPsy-CM working group
Collaborators, Affiliations

PEPsy-CM study protocol: impact of a 3-year program for early psychosis based on case-management on relapse rate, a French multicenter randomized trial

Aurélie Schandrin et al. BMC Psychiatry. .

Abstract

Background: Early intervention services (EIS) for early psychosis can help reduce the patient-specific and economic impacts of mental illness, but they are underdeveloped and practices are poorly harmonized in many countries.

Methods: The aim of the study is to evaluate in France the effectiveness of a three-year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in young people with a first episode of psychosis (FEP). Eligible participants are those aged between 16 and 30 years old consulting or hospitalized in mental health services for a FEP. Exclusion criteria include mental retardation, psychosis due to medication or medical condition. Four centers have so far joined the study and started recruiting. In this randomized controlled trial, the interventional group will receive TAU with the addition of intensive follow-up by a case manager, in accordance with EPPIC guidelines. The primary outcome is the percentage of participants relapsing at least once during the three-year follow-up, and time until first relapse. Secondary outcomes are relapse and hospitalization rate, adherence to care, clinical outcomes (psychotic et depressive symptoms, suicidal and aggressive behaviors, substance use), functional outcomes (living conditions, level of study or employment, social and occupational functioning), quality of life (patients and caregivers), users' satisfaction, direct and indirect costs and correct implementation of the intervention.

Discussion: The results from this study will be invaluable in characterizing the role of early intervention and case management, and establishing optimal care protocols to treat early psychosis in France. The study has encountered problems in attracting recruiting centers often to commit to randomization. The medico-economic evaluation is a strength of the study, as economic objectives are too infrequently considered in such studies.

Trial registration: www.

Clinicaltrials: gov number NCT05116514 registered on 05/10/2021.

Keywords: Assertive Community Treatment; Case-Management; Early Psychosis; First Episode of Psychosis.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The project has been approved by a Research Ethics Committee, committee for the protection of persons (CPP) Ile de France I. It was designed in line with the Declaration of Helsinki and registered at www.clinicaltrials.gov , NCT05116514. All changes to the protocol will be submitted for ethical approval and then forwarded to investigators and participants. Additionally, during the funding process, the protocol has undergone independent peer review. Participants are informed by investigators about the trial and about the voluntary nature of their participation with both written and verbal communications. Participants are only randomized following the provision of informed consent. Persons in mandatory care, often in inpatient unit, can consent to the study if their clinical condition allows it according to medical and participant evaluation. For minors, their consent and the consent of the two legal guardians are necessary. The choice of the treatment according to the randomization is explained to the participants as well as their families. If an ancillary or post-trial study is developed, it will be submitted for ethical approval. Consent for publication: Participants who give their informed consent for this study are informed of the use of their data for publication purposes. Any written or oral communication of the results of the research must receive the prior agreement of the coordinating investigator and the sponsor. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Time schedule of inclusion, assessments and visits for participants
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