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

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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3660-5) contains supplementary material, which is available to authorized users.