The Ohio State University Early Psychosis Intervention Center (EPICENTER) step-based care programme for individuals at clinical high risk for psychosis: study protocol for an observational study.

INTRODUCTION: In October 2018, the Substance Abuse and Mental Health Services Administration funded 21 sites throughout the USA to develop, implement and evaluate specialised care programmes for individuals at clinical high risk for developing a psychotic disorder (CHR-P). Per the funding requirements, such programmes were required to provide 'step-based care'-a model in which individuals are initially provided with low-intensity, non-psychosis-specific and more benign (ie, least side effects) interventions and only progress onto higher-intensity, psychosis-specific interventions with a greater risk of more severe side effects should they not meet a priori criteria for clinical response to such lower-intensity interventions. Here, we outline the evaluation component of the step-based care programme for individuals at CHR-P at The Ohio State University Early Psychosis Intervention Center (EPICENTER).

METHODS AND ANALYSES: The EPICENTER CHR-P programme provides a step-based care model comprising psychotherapy, medication management, family support/education, peer support and vocational/educational support. All participants who opt to receive care at the EPICENTER will complete a standardised assessment battery as part of usual care. This battery will be administered on enrolment and will be re-administered at 6-month intervals throughout individuals' participation in EPICENTER clinical services. Participants will have the opportunity to allow for data from these usual care assessments to be used as part of an evaluation project for this new clinical service. The primary outcome for this evaluation project is time to remission of symptomatic and functional deficits commonly experienced by individuals at CHR-P. Participants will also have the opportunity to participate in a supplemental research project designed to further evaluate treatment outcomes and patient characteristics among individuals participating in EPICENTER clinical services.

ETHICS AND DISSEMINATION: This project was approved by The Ohio State University Institutional Review Board. Results from this project will be disseminated through publications and presentations.

TRIAL REGISTRATION NUMBER: NCT03970005; Pre-results.