Taylor John A, Hall Deborah A, Walker Dawn-Marie, McMurran Mary, Casey Amanda, Stockdale David, Featherstone Debbie, Thompson Dean M, MacDonald Carol, Hoare Derek J
National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU UK.
Otology and Hearing Group, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.
Pilot Feasibility Stud. 2017 May 15;3:24. doi: 10.1186/s40814-017-0137-8. eCollection 2017.
Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within National Health Service (NHS) audiology in the United Kingdom (UK), no standard protocol currently exists for the treatment of tinnitus. Counselling is only available in less than half of audiology departments, and there is no agreed standard for what constitutes tinnitus counselling. There is substantial evidence from systematic reviews for the clinical benefit of cognitive behaviour therapy (CBT) for tinnitus delivered by clinical psychologists or psychiatrists, but no studies have sufficiently evidenced the NHS model of tinnitus care where management is increasingly being delivered by audiology professionals. In a pilot randomised controlled trial (RCT), this study aims to evaluate the feasibility of comparing a psychologically informed guidance manual developed to support audiologist management of tinnitus with usual treatment.
METHODS/DESIGN: Phase 1 consisted of three development stages: (1) a scoping review to generate a comprehensive set of tinnitus counselling components, (2) a Delphi survey involving expert patients ( = 18) and clinicians ( = 21) to establish consensus on the essential core attributes of tinnitus counselling, and (3) incorporation of these elements into a manualised care protocol. In phase 2, following training in a dedicated workshop, the manualised intervention will be delivered by three experienced audiologists across three different sites. Patients ( = 30) will be randomly allocated to receive either (1) psychologically informed management from an audiologist trained to deliver the manualised intervention or (2) treatment as usual (TAU) from an audiologist who has not received this training. Quantitative outcome measures will be administered at baseline, discharge and 6-month follow-up. Qualitative interviews with participating patients and clinicians will be conducted to gather perspectives on the feasibility and acceptability of the manualised intervention.
The feasibility of proceeding to a definitive RCT will be assessed via compliance with the manual, willingness to be randomised, number of eligible participants, rate of recruitment, retention and collection of quantitative outcome measures. This research offers an important first step to an evidence-based, standardised and accessible approach to tinnitus care.
ISRCTN13059163. Date of registration: 6 May 2016.
慢性耳鸣是一种常见的无法治愈的病症，常与抑郁、焦虑、失眠及生活质量下降相关。在英国国家医疗服务体系（NHS）的听力学领域，目前尚无治疗耳鸣的标准方案。不到半数的听力学科室提供咨询服务，且对于何为耳鸣咨询也没有公认的标准。系统评价有大量证据表明，临床心理学家或精神科医生提供的耳鸣认知行为疗法（CBT）具有临床益处，但尚无研究充分证明由听力学专业人员进行管理的NHS耳鸣护理模式的有效性。在一项试点随机对照试验（RCT）中，本研究旨在评估将为支持听力学专家管理耳鸣而制定的心理指导手册与常规治疗进行比较的可行性。
方法/设计：第一阶段包括三个开发阶段：（1）范围综述，以生成一套全面的耳鸣咨询组件；（2）德尔菲调查，涉及18名专家患者和21名临床医生，以就耳鸣咨询的基本核心属性达成共识；（3）将这些要素纳入手册化护理方案。在第二阶段，在一个专门的研讨会上进行培训后，由三名经验丰富的听力学专家在三个不同地点提供手册化干预。30名患者将被随机分配接受以下两种治疗之一：（1）由接受过手册化干预培训的听力学专家提供的心理指导管理；（2）由未接受过该培训的听力学专家提供的常规治疗（TAU）。将在基线、出院时和6个月随访时进行定量结果测量。将对参与的患者和临床医生进行定性访谈，以收集对手册化干预的可行性和可接受性的看法。
将通过对手册的依从性、随机分组意愿、合格参与者数量、招募率、保留率和定量结果测量的收集情况来评估进行确定性RCT的可行性。本研究为基于证据、标准化且可及的耳鸣护理方法迈出了重要的第一步。
ISRCTN13059163。注册日期：2016年5月6日。
