Baker Felicity A, Tamplin Jeanette, Clark Imogen N, Lee Young-Eun C, Geretsegger Monika, Gold Christian
The University of Melbourne, Melbourne, Victoria, Australia.
Norwegian Academy of Music, Oslo, Norway.
J Music Ther. 2019 May 10;56(2):125-148. doi: 10.1093/jmt/thy023.
High-quality clinical trials testing music therapy interventions have become more prevalent over the past decade. However, recent reviews of published music therapy trials reveal that reporting of strategies used to ensure treatment fidelity is lacking. Treatment fidelity refers to methodological strategies, put in place prior to clinical trial implementation, to strengthen the reliability and validity of intervention delivery and, therefore, safeguard research quality. This paper outlines strategies developed and implemented during the pilot phase of a randomized controlled trial involving the testing of music interventions for people living with dementia and presenting with symptoms of depression. We discuss the five recognized components of fidelity (study design, training intervention providers, treatment integrity, treatment differentiation, and treatment receipt) and describe our methods for training music intervention providers and testing interventionist competence prior to trial commencement, approaches to intervention delivery supervision, and methods for assessing intervention protocol adherence.
在过去十年中，测试音乐疗法干预措施的高质量临床试验变得更加普遍。然而，最近对已发表的音乐疗法试验的综述显示，用于确保治疗保真度的策略报告不足。治疗保真度是指在临床试验实施之前制定的方法策略，以加强干预实施的可靠性和有效性，从而保障研究质量。本文概述了一项随机对照试验试点阶段所制定和实施的策略，该试验涉及对患有痴呆症且伴有抑郁症状的人群进行音乐干预测试。我们讨论了保真度的五个公认组成部分（研究设计、培训干预提供者、治疗完整性、治疗区分和治疗接受情况），并描述了在试验开始前培训音乐干预提供者和测试干预者能力的方法、干预实施监督方法以及评估干预方案依从性的方法。
