Division of Psychology and Mental Health, School of Psychological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
J Clin Psychol. 2019 Oct;75(10):1756-1769. doi: 10.1002/jclp.22820. Epub 2019 Jun 25.
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.
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.
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.
Results support progressing to a larger trial of MOL for FEP. Recommendations for the design of future trials are provided.
我们旨在确定水平法（MOL）对于经历首发精神病（FEP）的人群的可行性和可接受性，以便为该疗法是否适合进一步在更大规模临床试验中进行测试做出决策。
采用平行组随机对照试验设计。参与者（N=36）被分配接受常规治疗（TAU）或 TAU 加 MOL。试验的招募和保留以及 MOL 干预的可接受性是主要结局。
在计划的时间框架内达到了招募目标。最终随访时的试验保留率为 97%，远高于作为成功可行性结果预先规定的 80%阈值。参与者的反馈提供了研究设计和干预措施对于这一人群的可接受性的初步证据。
结果支持进行更大规模的 MOL 治疗 FEP 的试验。为未来试验的设计提供了建议。
