Title: INVEST: Development and pilot evaluation of a new combined cognitive behavioural INtervention and vestibular rehabilitation for people with chronic VEstibular SympToms
Funder: Health Education England

Abstract: Background: The relationship between psychological factors and vestibular disorders has long been recognised. Psychological symptoms such as anxiety, depression, loss of balance confidence and negative beliefs about the consequences of dizziness and degree of handicap are commonplace in patients with chronic vestibular symptoms. Vestibular rehabilitation (VR) is an established treatment for vestibular dysfunction, although the benefits are not universal and do not always correlate with physical findings. The additional effect of combining cognitive behavioural interventions with VR remains unknown. The largest controlled trial to date had a positive outcome in the short-term, but no sustained benefits after 1 year. Previous studies have attempted to achieve adequate control of anxiety symptoms, although a more fruitful approach may be to combine VR with cognitive behavioural interventions targeted specifically for this population. Aims: (1) To conceptualise chronic vestibular symptoms within a cognitive-behavioural perspective outlining modifiable psychosocial factors (preliminary work - unfunded). (2) To determine the contribution of several potentially modifiable cognitive, behavioural and emotional factors to dizziness interference and severity. (3) To design a new integrated cognitive behavioural intervention specifically designed for patients with vestibular disorders based on the previous work. (4) To evaluate the feasibility and potential efficacy of the new combined cognitive behavioural intervention and (5) test multiple methodological components and clinical outcomes simultaneously to inform a fully powered randomised controlled trial.Methods: The project will follow the Medical Research Council framework for developing and evaluating complex interventions. Prior to the fellowship, a systematic review using narrative synthesis will identify potentially modifiable psychosocial factors in chronic vestibular symptoms. At the commencement of the fellowship a cross-sectional survey (n=200) including valid and reliable questionnaires will be conducted with patients experiencing vestibular symptoms. Hierarchical regressions will determine the relative contribution of psychosocial factors to predicting dizziness severity and interference. The survey results and review will inform the development of a combined treatment incorporating cognitive behavioural techniques alongside vestibular rehabilitation. For the parallel group randomised control pilot-feasability trial, 50 participants will be randomly assigned to the eight-week intervention or standard care rehabilitation group. Participants will complete validated measures at baseline, post intervention and three month follow up concerning dizziness interference (primary outcome), symptoms, anxiety, depression, postural control and quality of life and service costs. Potential Benefits: This project will improve our understanding of chronic vestibular symptoms. It will provide invaluable information to inform a larger scale trial of an intervention that could potentially improve the quality of life of sufferers, above and beyond standard physiotherapy care. By delivering the intervention as part of physiotherapy, this in turn will improve the access to psychological therapies and use of available resources; reduce the need for patients to see more than one healthcare professional and allow clinicians to respond to patient preference. Improving the outcome of rehabilitation may have additional beneficial social and economic implications as the patient is able to better manage their condition.

Lay abstract: Background: As many as 3 out of every 10 people have dizziness at some point of their life. It is one of the most common reasons why people go to see their doctor. The most common cause of dizziness is due to problems in the inner ear balance system, called the vestibular system. People who suffer with a vestibular problem can get a lot of different symptoms. These include dizziness, poor balance and feeling sick. Whilst many people with inner ear problems recover within several weeks, 1 in 5 people can experience dizziness for many years. Although it is rarely life threatening, it does greatly reduce the quality of someone's life. People with anxiety and depression are more likely to suffer from anxiety or depression than the general population. It is known that exercise can speed up recovery. Special exercises called vestibular rehabilitation' have been created to improve balance and reduce symptoms. However, not everybody gets better with this treatment and some benefit more than others. Studies have shown that psychological problems influence recovery to a greater extent than the degree of damage to the inner ear. Cognitive Behavioural Therapy (CBT) is a talking therapy that can help people with long term conditions by helping people deal with their problems in a more positive way. It is based on the concept that your thoughts, feelings, behaviour and physical symptoms are all connected, and that negative thoughts and feelings can sustain symptoms. A small number of studies have looked at CBT for people with inner ear problems. Unfortunately, the results are very mixed and the benefits do not appear to last very long. However, previous studies have not attempted to tailor the treatment specifically to the needs of people with balance problems. We may be able to improve the current treatments on offer for people with inner ear balance problems. The best way of doing that will be to combine exercises along with a new treatment that is drawn from cognitive behavioural therapies but is designed specifically for the needs of these patients. The treatment will be delivered by a physiotherapist. It is hoped that this will have a better chance of helping people with inner ear problems that would otherwise not improve with current rehabilitation treatment. Aim: To design and evaluate a new cognitive behavioural intervention that could improve the outcome of vestibular rehabilitation Design & Methods Used: There are different stages involved in developing and evaluating the new treatment: The first step is to pull together all the evidence from relevant studies to identify what psychological and social issues are linked with people who have had vestibular symptoms for a long time. The next step is to investigate these issues further. I will also think about psychological and social issues that are known to influence other health conditions but have not been investigated in people with inner ear balance problems. I will ask a large group of people with inner ear problems to complete a survey. This will help to confirm what the most important issues are. The results of the survey will help to identify where treatment could be enhanced to improve the outcome of rehabilitation.Finally, a small scale clinical trial will take place. The new treatment will combine elements of cognitive behavioural therapies and standard rehabilitation exercises. Patients who agree to take part will be put into 2 groups. A computer will assign each person into a group by chance. One group will receive the new combined treatment and the other group will receive standard rehabilitation exercises. Both treatments will be delivered by a physiotherapist. The results will help to design a larger trial in the future. Patient & Public Involvement: The feedback I have received from treating people with balance problems has led to me creating this project. The Meniere's Society also agrees that it is important and have helped to develop this proposal. Other groups that bring together patients and professionals have also identified the need for more research in this area. During the project, a public and patient involvement group will be created in order to give advice about the project. They will be actively involved in creating the new treatment to make sure it reflects the needs of people with balance problems. Dissemination: The results of the project will be: Presented at UK and International conferences Published in journals and will be available for everyone to access Presented at health professional courses Promoted through social media and newsletters Presented at patient groups

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: NEUROLOGICAL