Adaptation of a brief intervention to support engagement in early psychosis services: a service user-informed psychotherapy modification and study protocol.

UNLABELLED: Early intervention services (EIS) for psychosis are associated with improved clinical and functional outcomes, yet disengagement from treatment remains common. Psychological barriers to early engagement such as stigma, mistrust, and negative treatment expectancies have been identified yet few interventions have been developed to directly target these. Just Do You is a brief, psychotherapeutic meta-intervention originally developed for youth with severe mental illness to target identified barriers to engagement and has been demonstrated to improve engagement and recovery. However, the context of the original trial differs from Canadian early psychosis programs in setting, clinical population characteristics, and timing of delivery, necessitating adaptation for suitability in this context. This project comprises two phases. Phase 1, now complete and reported in this manuscript, used the Formative Method for Adapting Psychotherapy (FMAP) and the Psychotherapy Adaptation and Modification Framework (PAMF) to adapt Just Do You for a Canadian EIS. A multidisciplinary stakeholder group, including service users, participated in structured consultation meetings to guide the adaptation process. Their feedback aligned with four key domains: strengthening trust and autonomy, enhancing relevance to early psychosis, improving feasibility of delivery, and supporting continuity beyond sessions. Resulting modifications and the adapted intervention are described in depth in this manuscript. Phase 2 of this project, aims to evaluate the adapted intervention using a non-randomized wait-list control design. This manuscript also outlines the Phase 2 research protocol, including planned assessment procedures and analytic strategies. Findings from Phase 2 will inform future large-scale evaluation of the adapted intervention.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, Identifier NCT06410508.