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.

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

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CLINICALTRIALS

gov number NCT05116514 registered on 05/10/2021.