Method of Levels therapy for first-episode psychosis:The feasibility randomised controlled Next Level trial

Objective: We aimed to determine the feasibility and acceptability of Method of Levels (MOL) for people experiencing first-episode psychosis to inform decision making about the therapy’s suitability for further testing in a larger clinical trial. Method: A parallel group randomised controlled trial design was used. Participants (N = 36) were allocated to receive either treatment as usual (TAU) or TAU plus MOL. Recruitment and retention in the trial and the acceptability of the MOL intervention were the primary outcomes. Results: The recruitment target was met within the planned timeframe. Retention in the trial at final follow up was 97%, substantially higher than the 80% threshold pre-specified as a successful feasibility outcome. Participant feedback provided initial evidence of the acceptability of the study design and intervention for this population. Conclusion: Results support progressing to a larger trial of MOL for first-episode psychosis. Recommendations for the design of future trials are provided.