Care coordinator delivered method of levels therapy to improve engagement and other outcomes in early psychosis (CAMEO): A feasibility cluster-randomised controlled trial.

The Method of Levels (MOL) is a theoretically-informed, transdiagnostic cognitive therapy that could improve service user engagement and recovery for individuals with early psychosis. We aimed to assess the feasibility and acceptability of training care coordinators in early intervention in psychosis teams to deliver MOL, and to assess the feasibility of conducting a two-arm parallel-group cluster-randomised controlled trial (C-RCT) with randomisation at the level of teams. Randomisation was in a ratio of 1:2 to either (1: control) treatment as usual (TAU); or (2: intervention) TAU plus support from a care coordinator who has received training in MOL. Clinical and health economic outcomes were collected at baseline, three, and six months. Fourteen early intervention in psychosis teams (117% of target), 31 care coordinators (129% of target), and 49 service users (51% of target) were recruited. Results suggest that some aspects of this study are feasible in their current form (e.g., care coordinator recruitment), other aspects are likely to be feasible with relatively minor adjustments (e.g., service user retention), and some aspects would need substantial changes to make the delivery of an evaluation C-RCT feasible (e.g., service user recruitment; MOL supervision for care coordinators). Progression to an evaluation trial would be justified if plausible solutions can be found to address the feasibility issues identified in this study.