A feasibility study of psychologically informed vestibular rehabilitation for persistent dizziness

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: This is a randomised controlled feasibility trial. It also includes nested qualitative interviews with participants. The objective is to gather preliminary information in preparation for conducting a full‐scale trial in the future. Participants will be recruited from the audiovestibular (balance) clinic at St George's Hospital, London. They will be given an information sheet and approached to screen for eligibility by a member of the healthcare team. Eligible participants wishing to take part in the trial will sign a written consent form indicating that they have read and understood the information sheet and have opportunity to answer any further questions. Participants will then attend a testing appointment, where they will complete a set of baseline self report questionnaires and a test of their balance/walking. Once they have completed the baseline measures they will be randomly allocated to either the intervention and usual care physiotherapy, by a computer. A total of 20 participants will be allocated to each arm, who will complete 6 sessions of physiotherapy over 12‐14 weeks. Sixteen weeks after they were randomised they will attend another appointment to complete the same questionnaires and balance test they did at baseline to see if there has been any changes. A proportion of participants in the intervention group will be invited to participate in semi‐structured interviews to discuss the acceptability and feasibility of the trial, including the recruitment processes, randomisation, retention, and outcome measures. The treatment in the intervention arm will mirror the best practice physiotherapy (vestibular rehabilitation) guidelines but also include elements of cognitive‐behavioural therapy (CBT). The purpose CONDITION: Chronic dizziness ; Signs and Symptoms ; Dizziness and giddiness PRIMARY OUTCOME: ; Primary feasibility outcomes collected at the end of the trial:; 1. Suitability of eligibility criteria measured by recording the number of people excluded from the trial; 2. Willingness to participate measured by the proportion of eligible patients who agree to participate; 3. Retention rates measured by the proportion of participants who were randomised that completed follow‐up assessment as well as recording of attendance at therapist sessions; 4. Time needed to collect and analyse data measured by timesheets; 5. Acceptability of the intervention measured at 4 months up using a questionnaire based on the component constructions in the theoretical framework of acceptability; INCLUSION CRITERIA: 1. Patients attending the neuro‐otology balance clinic at St George’s University Hospitals Foundation Trust with symptoms of chronic dizziness (>= 3 months) made worse by movement of the self and/or the environment 2. Dizziness Handicap Inventory (DHI) > = 40 3. Aged > = 18 years 4. Not currently participating in vestibular rehabilitation or psychological treatment (talking therapies) 5. Able to provide consent and willing to comply with the proposed training and testing regime SECONDARY OUTCOME: ; Secondary feasibility outcomes measured at baseline and 4 months:; 1. Dizziness handicap is measured using the Dizziness Handicap Inventory (DHI); 2. Visually induced dizziness is measured using the Visual Vertigo Analogue Scale (VVAS); 3. Dizziness interference is measured using the visual analogue scale (VAS); 4. Health‐related quality of life is measured using the European Quality of Life questionnaire EQ5D (EuroQol); 5. Balance is measured using the mini‐Balance Evaluation Systems Test (mini‐BEStest); ; Process outcome measures measured at baseline and 4 months:; 1. Illness perceptions are measured using the Brief Illness Perception Questionnaire (B‐IPQ); 2. Cognitive and behavioural responses to dizziness are measured using the Cognitive and Behavioural Responses to Symptoms Questionnaire (CBRSQ); 3. Anxiety is measured using the Generalised Anxiety Disorders‐7 Questionnaire (GAD‐7); 4. Depression is measured using the Patient Health Questionnaire‐9 (PHQ‐9);
Epistemonikos ID: 4b77fd90f93366b4357ca2bf30ac153b9b56e70f
First added on: Aug 24, 2024