Rationale, design and baseline data of the Next Level study: Feasibility randomised controlled trial of Method of Levels therapy for first-episode psychosis

Background: Method of Levels (MOL) is an innovative transdiagnostic cognitive therapy with potential advantages over existing psychological treatments for psychosis.
Aims: The Next Level study is a feasibility randomised controlled trial of MOL for people experiencing first-episode psychosis. It aims to determine the suitability of MOL for further testing in a definitive trial.
Method: The study uses a parallel group non-blind feasibility randomised controlled trial design with two conditions: (1) treatment as usual (TAU) and (2) TAU plus MOL. Participants (N=36) were recruited from early intervention in psychosis services. Outcome measures are completed at baseline, 10 and 14 months. The primary outcomes are recruitment and retention.
Results: Participants’ demographic and clinical characteristics are presented along with baseline data.
Conclusions: Next Level has recruited to target, providing evidence that it is feasible to recruit to a randomised controlled trial of MOL for first-episode psychosis.