The INVEST trial: a randomised feasibility trial of psychologically informed vestibular rehabilitation versus current gold standard physiotherapy for people with Persistent Postural Perceptual Dizziness.
J Neurol
; 269(9): 4753-4763, 2022 Sep.
Article
em En
| MEDLINE
| ID: mdl-35397754
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vestíbulo do Labirinto
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Tontura
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
Limite:
Adult
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Humans
Idioma:
En
Revista:
J Neurol
Ano de publicação:
2022
Tipo de documento:
Article