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

Kristiansen et al. Trials (2019) 20:575 https://doi.org/10.1186/s13063-019-3660-5 STUDY PROTOCOL Open Access 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 Lene Kristiansen1* , L. H. Magnussen1, K. T. Wilhelmsen1, S. Mæland1, S. H. G. Nordahl2,3, R. Clendaniel4, A. Hovland5,6 and B. Juul-Kristensen7 Abstract 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. Keywords: Protocol, RCT, Persistent dizziness, Vestibular rehabilitation, Cognitive behaviour therapy, Dizziness Handicap Inventory, Gait velocity, Rehabilitation * Correspondence: 1 Department of Health and Functioning, Faculty of Health and Social Sciences, Western Norway University of Applied Sciences, Bergen, Norway Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Kristiansen et al. Trials (2019) 20:575 Background Vertigo and/or dizziness are amongst the most frequent symptoms reported in outpatient practices [1], with a lifetime prevalence reported in approximately 30% [2]. Dizziness can present for a variety of reasons, many initiated through vestibular disease; however, it is not always possible to identify a specific cause or diagnosis [3]. Psychological factors, such as anxiety, seem to be closely related to the prevalence of dizziness [4, 5], and it is likely that biological and psychological factors interact, maintaining the vestibular symptoms as well as the anxiety [4, 6]. In chronic dizziness it is common to avoid movements, activities and social settings that may provoke symptoms and discomfort [7]. This fear of provoking dizziness and discomfort may also lead to an ‘en bloc’ movement pattern. Some studies on persons with persistent dizziness have also reported musculoskeletal symptoms [8] like, for instance, postural malalignments [9] and musculoskeletal pain [10], particularly in the neck-shoulder area [10–12]. Long-term consequences of such avoidance strategies may hamper compensation strategies and functional improvements, eventually leading to occupational disability [13]. Vestibular Rehabilitation (VR) is an exercise-based treatment approach for dizziness, primarily directed towards reducing vestibular symptoms (not musculoskeletal aberrations), with moderate to strong evidence of VR for conditions of unilateral vestibular hypofunction [14]. A recent review has indicated that VR may also be used in other conditions such as vestibular disorders of central origin [15]. Since musculoskeletal symptoms are not specifically targeted in VR interventions, one longitudinal study (no control group) incorporated bodyawareness therapy [16] into VR, with positive effects on musculoskeletal aberrations, such as improved bodily flexibility and balance during ambulation, as well as improved perception of dizziness [17, 18]. As mentioned, VR treatment is developed as an exercisebased treatment; however, it also contains some cognitive elements, such as graded exposure (habituation), that also facilitates cognitive restructuring (e.g. reduce avoidance behaviour) [7, 19]. A recent randomised controlled trial (RCT), providing just three sessions of Cognitive Behaviour Therapy (CBT) for panic anxiety, found reduced dizziness, handicap and use of safety behaviours in persons with chronic subjective dizziness [20]. Furthermore, the positive changes were maintained at 6-month follow-up [21], but the outcomes only focussed on psychological complaints, and no objective outcomes were assessed. As both VR and CBT have shown positive effects on persons with dizziness, the combination of VR and CBT seems to be an appropriate treatment approach for persistent dizziness, and a few studies have investigated this combination [22–25]. The effects of the combined VR and CBT treatments are reported to be reduced dizziness- Page 2 of 11 related handicap [23–25], improved walking [23], and reduced anxiety and depression [25]. A systematic review on psychotherapy in dizziness found a small and clinically relevant effect on dizziness, but no effect on anxiety and depression [26]. However, the included studies had small sample sizes (19 to 31 participants) [23–25], no random allocation [25], no standardised CBT treatment manual [25], and improvements found in the short-term were not maintained as long-term effects [22]. Further, as none of the combined treatments included a focus on musculoskeletal complaints, there is a need to further develop the treatment comb (...truncated)