Method of levels therapy for first-episode psychosis: The feasibility randomized controlled Next Level trial

J Clin Psychol. 2019 Oct;75(10):1756-1769. doi: 10.1002/jclp.22820. Epub 2019 Jun 25.

Abstract

Objective: We aimed to determine the feasibility and acceptability of Method of Levels (MOL) for people experiencing first-episode psychosis (FEP) to inform decision making about the therapy's suitability for further testing in a larger clinical trial.

Method: A parallel group randomized 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 time frame. Retention in the trial at final follow-up was 97%, substantially higher than the 80% threshold prespecified 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 FEP. Recommendations for the design of future trials are provided.

Keywords: Method of Levels; early intervention; feasibility; first-episode psychosis; psychotherapy; randomized controlled trial.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cognitive Behavioral Therapy*
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Patient Acceptance of Health Care
  • Process Assessment, Health Care*
  • Psychotic Disorders / therapy*
  • Young Adult