前庭康复与认知行为疗法联合应用于初级保健持续性头晕患者的疗效：一项随机对照试验的研究方案。
Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial.
机构信息
Department of Health and Functioning, Faculty of Health and Social Sciences, Western Norway University of Applied Sciences, Bergen, Norway.
Norwegian National Advisory Unit on Vestibular Disorders, Department of Otorhinolaryngology and Head Neck Surgery, Haukeland University Hospital, Bergen, Norway.
出版信息
Trials. 2019 Oct 7;20(1):575. doi: 10.1186/s13063-019-3660-5.
BACKGROUND
Dizziness is a common complaint, and the symptom often persists, together with additional complaints. A treatment combining Vestibular Rehabilitation (VR) and Cognitive Behaviour Therapy (CBT) is suggested. However, further research is necessary to evaluate the efficacy of such an intervention. The objective of this paper is to present the design of a randomised controlled trial aiming at evaluating the efficacy of an integrated treatment of VR and CBT on dizziness, physical function, psychological complaints and quality of life in persons with persistent dizziness.
METHODS/DESIGN: The randomised controlled trial is an assessor-blinded, block-randomised, parallel-group design, with a 6- and 12-month follow-up. The study includes 125 participants from Bergen (Norway) and surrounding areas. Included participants present with persistent dizziness lasting for at least 3 months, triggered or exacerbated by movement. All participants receive a one-session treatment (Brief Intervention Vestibular Rehabilitation; BI-VR) with VR before being randomised into a control group or an intervention group. The intervention group will further be offered an eight-session treatment integrating VR and CBT. The primary outcomes in the study are the Dizziness Handicap Inventory and preferred gait velocity.
DISCUSSION
Previous studies combining these treatments have been of varying methodological quality, with small samples, and long-term effects have not been maintained. In addition, only the CBT has been administered in supervised sessions, with VR offered as home exercises. The current study focusses on the integrated treatment, a sufficiently powered sample size, and a standardised treatment programme evaluated by validated outcomes using a standardised assessment protocol.
TRIAL REGISTRATION
www.clinicaltrials.gov, ID: NCT02655575 . Registered on 14 January 2016.
背景
头晕是一种常见的主诉，且该症状常持续存在，并伴有其他附加症状。建议采用前庭康复（VR）和认知行为疗法（CBT）联合治疗。然而，需要进一步的研究来评估这种干预的疗效。本文旨在介绍一项随机对照试验的设计，该试验旨在评估 VR 和 CBT 联合治疗对持续性头晕患者的头晕、身体功能、心理症状和生活质量的疗效。
方法/设计：这项随机对照试验是一项评估员盲法、分组随机、平行组设计，有 6 个月和 12 个月的随访。该研究包括来自卑尔根（挪威）及周边地区的 125 名参与者。纳入的参与者存在持续至少 3 个月的头晕，由运动触发或加重。所有参与者均接受一次治疗（简短干预性 VR；BI-VR），然后进行 VR 治疗，再随机分为对照组或干预组。干预组将进一步接受 8 次整合 VR 和 CBT 的治疗。研究的主要结局是头晕障碍量表和首选步态速度。
讨论
以前结合这些治疗方法的研究具有不同的方法学质量，样本量较小，长期效果无法维持。此外，仅对 CBT 进行了监督治疗，而 VR 则作为家庭锻炼提供。本研究侧重于整合治疗、足够的样本量、以及通过使用标准化评估方案评估的标准化治疗方案。
试验注册
www.clinicaltrials.gov，编号：NCT02655575。于 2016 年 1 月 14 日注册。
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