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Protocol for a randomised controlled feasibility study of psychologically informed vestibular rehabilitation for people with persistent dizziness: INVEST trial
Pilot and Feasibility Studies Pub Date : 2021-08-16 , DOI: 10.1186/s40814-021-00896-y
David Herdman 1, 2 , Sam Norton 1 , Marousa Pavlou 3 , Louisa Murdin 4, 5 , Rona Moss-Morris 1
Affiliation  

Dizziness is a common complaint that often persists and leads to disability and distress. Several cognitive and behavioural responses may contribute to the neurobiological adaptations that maintain persistent vestibular symptoms. This paper will present the protocol of a two-arm parallel group feasibility randomised controlled trial designed to determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of an integrated cognitive behavioural therapy and vestibular rehabilitation (CBT-VR) treatment for people with persistent dizziness. Forty adult patients will be recruited from a tertiary vestibular clinic with persistent movement–triggered dizziness for 3 months or longer who have moderate–high levels of dizziness handicap. Participants will be 1:1 randomised, using a minimisation procedure, to six sessions of either CBT-VR (intervention arm) or VR only (control arm). Measures will be collected at baseline and 4 months post randomisation. The primary feasibility outcomes include descriptive data on numbers meeting eligibility criteria, rates of recruitment, numbers retained post randomisation, treatment adherence and an acceptability questionnaire. Treatment effects on self-report outcomes will be estimated to determine that 95% confidence intervals for the effects are consistent with anticipated effects and minimum clinically important differences, and to provide information needed for the power calculation of an efficacy trial. A nested qualitative study will be conducted post-intervention (intervention group only) to explore the acceptability of the intervention and identify any areas in need of improvement. If a trial of CBT-VR is feasible, acceptability data will be used to enhance the intervention if needed and refine the multicentre RCT protocol. Future studies will need to consider the training required for other physiotherapists to deliver the intervention. ClinicalTrials.gov, ISRCTN 10420559

中文翻译:

持续性头晕患者心理知情前庭康复随机对照可行性研究方案:INVEST 试验

头晕是一种常见的抱怨,经常持续存在并导致残疾和痛苦。几种认知和行为反应可能有助于维持持续前庭症状的神经生物学适应。本文将介绍一项两臂平行组可行性随机对照试验的方案,旨在通过检查综合认知行为疗法和前庭康复 (CBT) 的招募可行性、可接受性和潜在益处来确定是否可以实现完全有效的疗效试验-VR) 治疗持续性头晕的人。将从三级前庭诊所招募 40 名患有持续运动引发的头晕 3 个月或更长时间且具有中度至高度头晕障碍的成年患者。参与者将按 1:1 随机分配,使用最小化程序,进行六次 CBT-VR(干预臂)或仅 VR(控制臂)会话。将在基线和随机化后 4 个月收集测量值。主要可行性结果包括关于符合资格标准的人数、招募率、随机化后保留的人数、治疗依从性和可接受性问卷的描述性数据。将估计对自我报告结果的治疗效果,以确定效果的 95% 置信区间与预期效果和最小临床重要差异一致,并提供疗效试验功效计算所需的信息。干预后(仅限干预组)将进行嵌套定性研究,以探索干预的可接受性并确定任何需要改进的领域。如果 CBT-VR 试验可行,可接受性数据将在需要时用于加强干预并完善多中心 RCT 协议。未来的研究将需要考虑其他物理治疗师提供干预所需的培训。ClinicalTrials.gov, ISRCTN 10420559
更新日期:2021-08-16
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