Peter Taylor, Isabel Adeyemi, Martin Eden, Samantha Hartley, Mark Hann, Cameron Latham, Sarah Parry, Catherine Robinson, Stephen Kellett
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引用次数: 0
Abstract
Background: Self-harm is a major health concern amongst young people that is increasing in prevalence. Cognitive analytic therapy (CAT) is a relational, integrative psychotherapy that is theoretically consistent with our growing understanding of self-harm. The aim of this study was to ascertain the feasibility and acceptability of evaluating brief CAT in young people aged 13-17 who self-harm using a randomised controlled trial (RCT) design.
Method: Sixty young people with experiences of self-harm will be recruited from child and adolescent mental health services. Participants will be randomly allocated (1:1 ratio) to brief CAT plus treatment as usual (TAU) or TAU alone. Assessors will be blind to treatment allocation. Assessments will occur at baseline, 8, 16, and 20 weeks after randomisation. A qualitative process evaluation will investigate experiences of the therapy and trial procedures. The primary outcome for this study is feasibility, judged against a priori progression criteria relating to recruitment, retention, adherence to therapy, and missing data.
Discussion: Brief CAT may help young people struggling with self-harm, but research is needed. In order to undertake a definitive RCT, it is first necessary to resolve a number of feasibility uncertainties. The planned feasibility trial will help inform a larger definitive trial focused on the efficacy of brief CAT for young people who self-harm.
Trial registration: The trial was pre-registered (01/08/25) on ISR CTN (ISRCTN code: ISRCTN11505839).
期刊介绍:
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.