ABSTRACT

Introduction

Treatment manuals play an essential role in clinical trials that aim to determine the efficacy of an intervention. Yet, the idea of needing to adhere to a treatment manual may seem counterintuitive to many music therapy clinicians. The purpose of this article is to offer clinician, supervisor, and researcher perspectives on the process of developing and executing a manualized music therapy treatment protocol in a randomized controlled trial.

Method

After describing the purpose of treatment manuals in clinical trials, we present the experience of developing a treatment manual through clinician and researcher collaborations. The concept of treatment fidelity and quality assurance monitoring within clinical trials is detailed to provide an inside look at an integral aspect of enacting treatment manuals in efficacy research. We then share reflections from a research clinician and supervisor to demonstrate the opportunities and challenges when working within the guidelines of manualized clinical practice.

Results

Providing a reflective perspective on implementation of a manualized treatment protocol allows for a more thorough understanding of the clinical and research processes in the conduct of randomized controlled trials.

Discussion

Collaboration of researchers, clinicians and supervisors is of critical importance for the successful implementation of treatment manuals in clinical trials.

中文翻译：

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实施治疗手册的经验：临床医生、主管和研究人员的反思

摘要

介绍

治疗手册在旨在确定干预效果的临床试验中发挥着重要作用。然而，对于许多音乐治疗临床医生来说，需要遵守治疗手册的想法似乎违反直觉。本文的目的是为临床医生、主管和研究人员提供关于在随机对照试验中开发和执行手动音乐疗法治疗方案的过程的观点。

方法

在描述了临床试验中治疗手册的目的之后，我们介绍了通过临床医生和研究人员合作开发治疗手册的经验。详细介绍了临床试验中的治疗保真度和质量保证监测的概念，以提供对在疗效研究中制定治疗手册的一个组成部分的内部观察。然后，我们分享研究临床医生和主管的思考，以展示在手动临床实践指导下工作时的机遇和挑战。

结果

提供对手动治疗方案实施的反思性观点，可以更透彻地了解随机对照试验中的临床和研究过程。

讨论

研究人员、临床医生和主管的合作对于在临床试验中成功实施治疗手册至关重要。