Title: Development and evaluation of a complex needs digital intervention for education and self-management of hyperacusis
Funder: Department of Health and Social Care

Abstract: Background Hyperacusis is a hearing disorder affecting 9% of adults and children. It involves increased sensitivity or decreased tolerance to everyday sound that would not trouble most individuals. It can be chronic, and leads to debilitating feelings of fear, distress, anxiety, and inability to cope. People suffering from hyperacusis are often isolated, unable to function in daily life, work, socialise, or even interact with friends and family. These problems are exacerbated by a lack of knowledge about hyperacusis and appropriate coping strategies.Although mechanisms of hyperacusis have been proposed, it remains medically unexplained with no definitive aetiology or cure. Healthcare therefore focuses on management of hyperacusis-related problems. Currently, there are no clinical guidelines for the management of hyperacusis. Strategies are generally borrowed' from Tinnitus Retraining Therapy or Cognitive Behavioural Therapy (CBT). Importantly, patients agree that education, counselling, or CBT are important for managing hyperacusis. Yet no intervention has been systematically developed specifically for those with hyperacusis. An online educational, self-help intervention for hyperacusis may be a viable option. Online education, and self-help interventions, reduce psychological distress and anxiety, provide immediate patient benefit and offer an alternative option for those unable or unwilling to attend clinics or access psychotherapeutic interventions. When asked, people experiencing hyperacusis valued the development of an online intervention as it can be accessed and used in a preferred sound environment (compared to visiting a noisy healthcare setting for example).Aim To develop and evaluate an unguided educational and self-help digital intervention for the complex needs of those with hyperacusis.Methods This work is guided by the Medical Research Council (MRC) four-stage framework (2008) for developing and evaluating complex interventions. Evidence-, theory-, and person-based approaches will be incorporated to ensure acceptability, feasibility, and effectiveness of the intervention.Stage 1. Planning (Months 1-12) To conceptualise patient and professionals needs, experiences, barriers, and challenges of hyperacusis and digital implementation of self-management through semi-structured interviews. Stage 2. Design (Months 10-17) To map hypothesised mechanisms underpinning target behaviour, the behavioural mediators and underpinning theories to change health beliefs and behaviour using behavioural analysis and a logic model. Stage 3. Development, and evaluation of acceptability and feasibility (Months 18-36) To determine user reactions through think-aloud interviews and modify the intervention to optimise acceptability and likely effectiveness. To evaluate feasibility of delivering and trialling an unguided digital intervention for hyperacusis, in terms of recruitment rates, timing, compliance with the intervention and user reactions to the intervention. Anticipated impact and dissemination A high-quality digital educational resource and intervention product delivered online will be designed to provide improved access to education on hyperacusis, support, and tools to self-manage, all working towards improvements in hyperacusis-related problems. It will also have the added benefit of providing healthcare professionals with an immediate resource to guide management of hyperacusis patients, which will address a gap in current healthcare practice. Progress during the project will be reported at national and international conferences and published in high-impact scientific journals.

Lay abstract: Some people have real difficulty coping with everyday sounds such as car noise, dishwashers, or people talking. This is a hearing problem called hyperacusis. People with hyperacusis report that everyday sounds are intense, frightening, painful, or overwhelming. This often leads to feelings of fear, anger, distress, or anxiety. People can become isolated and lose independence. They often avoid situations such as shopping or seeing a doctor because they are worried about the noise level. Every aspect of life, work, education, spending time with family and friends, can be affected. Underpinning a lot of these problems is a lack of knowledge of the condition or how best to cope with it. The aim of this project is to create a reliable educational tool to support people with hyperacusis to learn about hyperacusis and how they can best help themselves in everyday situations.Hyperacusis affects about one in ten adults and children. Many also have other conditions such as tinnitus, chronic pain, depression, post-traumatic stress syndrome, autism, or dementia. Currently there is no cure for hyperacusis, and no guidelines on how best to care for people who have it. Things that are tried include counselling or using sound which are typically used for other hearing problems such as tinnitus. Importantly, no therapy has ever been developed specifically for people with hyperacusis.Learning about the condition, counselling, and psychological therapy have been judged by patients as important for treating hyperacusis. To that end, the internet is a useful way to provide high-quality information to a large number of people who have hyperacusis. The internet is easily accessed by most people and a cost-effective way of helping large numbers. It offers the means to educate and support people, for example by teaching about self-help.Self-help tools involve people working through a set of materials designed to educate and reassure. They can be delivered online and for other conditions have been found to reduce distress and anxiety. When self-help materials are delivered online they can be easily tailored to the different needs of different people. They offer an alternative option for those unable or unwilling to attend clinics or to access counselling or other face-to-face therapy. When asked, people with hyperacusis valued the development of an online intervention as it can be accessed and used in their preferred sound environment.There are no dedicated UK charities for hyperacusis, little or no community care, support, or resources, and no formal guidelines on hyperacusis for healthcare professionals to work with. This adds up to an urgent need to develop and test a digital self-help educational tool. This project will involve working closely with patients to develop online education on hyperacusis, support, and techniques to improve the lives of people with hyperacusis. Key stages of the project are:Planning: Interviews to understand beliefs, needs, and challenges related to hyperacusis. Design: Combine evidence from people's experience of hyperacusis and research to determine the main aims and content of the educational tool. Development: Interviews to determine whether the educational tool is acceptable, useable, and appropriate for people who have hyperacusis. Make any necessary changes to the educational tool to improve acceptability and likely effectiveness. Testing: Test to see what worked and what did not, whether people used all the self-help materials, how many people would be needed to do a full scale clinical trial, and whether healthcare professionals used this tool. Patient experiences and research evidence will be considered at every stage. Progress during the project will be reported at key conferences and published in magazines and scientific journals.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: EAR