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Randomized Controlled Trial
. 2022 Sep;269(9):4753-4763.
doi: 10.1007/s00415-022-11107-w. Epub 2022 Apr 10.

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

David Herdman  1   2 , Sam Norton  1   3 , Louisa Murdin  4   5 , Kate Frost  2 , Marousa Pavlou  6 , Rona Moss-Morris  7
Affiliations
Randomized Controlled Trial

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

David Herdman et al. J Neurol. 2022 Sep.

Abstract

Background: Persistent postural perceptual dizziness (PPPD) is a common and disabling functional neuro-vestibular disorder. We aimed to determine the feasibility and acceptability of conducting a randomised controlled trial of cognitive-behavioural therapy informed vestibular rehabilitation (INVEST intervention) designed for persistent dizziness.

Methods: A two-armed parallel groups randomised feasibility study of INVEST vs. a time-matched gold standard vestibular rehabilitation (VRT) control. Participants with PPPD were recruited from a specialist vestibular clinic in London, UK. Participants were individually randomised using a minimisation procedure with allocation concealment. Measures of feasibility and clinical outcome were collected and assessed at 4 months.

Results: Forty adults with PPPD were randomised to six sessions of INVEST (n = 20) or gold standard VRT (n = 20). Overall, 59% of patients screened met the inclusion criteria, of which 80% enrolled. Acceptability of INVEST, as assessed against the theoretical framework of acceptability (TFA), was excellent and 80% adhered to all 6 sessions. There were small to moderate treatment effects in favour of INVEST across all measures, including dizziness handicap, negative illness perceptions, symptom focussing, fear avoidance, and distress (standardised mean difference [SMD]g = 0.45; SMDg = 0.77; SMDg = 0.56; SMDg = 0.50, respectively). No intervention-related serious adverse events were reported.

Conclusions: The study results give strong support for the feasibility of a full-scale trial. Both arms had high rates of recruitment, retention, and acceptability. There was promising support of the benefits of integrated cognitive-behavioural therapy-based vestibular rehabilitation compared to gold standard vestibular rehabilitation. The study fulfilled all the a-priori criteria to advance to a full-scale efficacy trial.

Trial registration number: ISRCTN10420559.

Keywords: Cognitive behavioral therapy; Dizziness; Feasibility; PPPD; Vestibular; Vestibular rehabilitation.

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Conflict of interest statement

None.

Figures

Fig. 1
Fig. 1
Participant flow diagram. DHI dizziness handicap inventory
Fig. 2
Fig. 2
Likert scale acceptability data according to group allocation. INVEST integrated intervention, VRT gold standard vestibular rehabilitation
Fig. 3
Fig. 3
Treatment effect sizes and confidence intervals
See this image and copyright information in PMC

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