Protocol for a randomised controlled feasibility study of psychologically informed vestibular rehabilitation for people with persistent dizziness: INVEST trial

Abstract

Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov, ISRCTN 10420559

Impact and experiences of vestibular disorders and psychological distress: Qualitative findings from patients, family members and healthcare professionals

“…Recently, combined approaches delivering cognitive behavioural therapy and vestibular rehabilitation concurrently were found to reduce dizziness handicap, psychological distress, and avoidance amongst patients with persistent dizziness. 68,69 Our findings lend support to this model and suggest that further roll-out would be worthwhile, as well as future research investigating the longer term impacts of these interventions on daily activities, social engagement and clinical recovery.…”

The INVEST trial: a randomised feasibility trial of psychologically informed vestibular rehabilitation versus current gold standard physiotherapy for people with Persistent Postural Perceptual Dizziness

“…Participants in the INVEST arm were also invited to participate in a qualitative interview after T1 (results will be reported elsewhere). There were no changes from the published research protocol, which contains more detailed methods and intervention specifics [ 16 ].…”

“…The interventions are detailed in the protocol [ 16 ]. Each arm was delivered by a different senior specialist grade physiotherapist (DH and KF).…”

“…Participants completed all self-report measures online at T0 and T1 independently at home including measures of Dizziness Handicap (DHI) [ 21 ], visually induced dizziness (Visual Vertigo Analogue Scale [VVAS]) [ 8 ], dizziness interference (percentage of time symptoms interfere with life [%TSI]) [ 13 ] and health status (European Quality of Life questionnaire [EQ5D]) [ 12 ]. All scales are previously well-validated in people with chronic dizziness (see protocol for details) [ 16 ].…”

“…Specific objectives were to determine the recruitment and retention rate, to test the utility of a range of outcome measures, levels of acceptability, assess adherence and to collect outcome data to explore treatment effects and estimate key elements that would inform a large-scale trial. For a breakdown of the detailed study objectives and predefined progression criteria, please see the published protocol [ 16 ].…”