Title: Digital guided self-help for binge eating disorder: Devising an effectiveness study and testing its acceptability and feasibility
Funder: Health Education England

Abstract: Digital guided self-help for binge eating disorder:Devising an effectiveness study and testing its acceptability and feasibility Background Binge Eating Disorder (BED) is a common psychiatric disorder associated with significant psychological, physical and social morbidity. It tends to run a chronic course. Its prevalence is estimated as 3.2% of the population aged 16 years or over, equivalent to about 1.4 million sufferers in England. The NICE guidelines recommend a stepped care approach to the management of BED. The first step is 'Guided Self-Help' (GSH) in which the individual follows a self-help programme with guidance from a non-specialist. Conventionally, the programme is printed. I have led the development of a digital programme; one that can be used via a mobile application or the internet. It has been directly derived from the leading, NICE-endorsed, face-to-face psychological treatment for BED. This sophisticated digital programme, capable of personalising the treatment to match important details of an individual's eating disorder, is likely to enhance the potency and accessibility of GSH.A proof-of-concept study of this digital programme has shown that it is well accepted and can have a major impact. It requires definitive evaluation to establish its clinical and cost effectiveness. First, preparatory research is needed to optimise the design and implementation of the future clinical trial. The proposed research is concerned with such preparatory work. The findings will also have relevance for researchers considering the feasibility of similar interventions and trials. People with binge eating disorder were involved in the development of the treatment and this research proposal.AimsTo evaluate the acceptability and feasibility of a randomised controlled trial (RCT) designed to assess the clinical and cost-effectiveness of the new Digital GSH programme for BED. Key aspects of the future definitive RCT will be investigated; namely, recruitment, outcome measures, assessments, treatment uptake and completion, and PPI. On completion, it will be decided whether it is appropriate to progress to a definitive trial and, if so, how best to optimise its design and implementation. Plan of investigation Phase One - A systematic review and meta-analysis of existing controlled studies of digital treatments for BED will be conducted. This review will inform major aspects of the future trial; including outcomes, recruitment strategy and assessment. Phase Two - Three focus groups with stakeholders (people with BED, primary care health practitioners, and eating disorder professionals) will be undertaken to obtain their perspectives on what can be done to ensure the success and relevance of the full trial.Phase Three - A feasibility RCT comparing Digital GSH with conventional Printed GSH, with a nested qualitative study, will be undertaken. PPI members will be involved in each phase and in the dissemination of findings.Potential benefitsDigitalising GSH for BED is likely to improve access to this NICE-endorsed treatment, as well as enhancing its clinical and cost effectiveness. This will shorten the course of the eating disorder, thereby reducing the suffering of patients and costs to the NHS.

Lay abstract: Digital Guided Self-Help for Binge Eating Disorder Background Binge Eating Disorder is a common mental health problem which can last a long time. It has a major impact on people's psychological and physical health and their quality of life. It affects around 3% of the population: that is about 1.4 million people in England. A treatment called 'guided self-help' is recommended as the first step in the treatment of BED. It involves the person concerned following a self-help programme with support from a non-specialist worker whose role is to help the person follow the programme. Usually the self-help programme is presented in printed form, often as a book. From within our research group, I have led the development of a new digital programme that can be used on a smartphone or computer. It is based closely on the leading face-to-face psychological treatment (also developed by our research group). A digital programme has a major advantage over a one-size-fits-all book, as it can be programmed to generate a personalised treatment that matches the issues facing the individual. Like conventional guided self-help, it will be accompanied by outside support. The support will be delivered over the telephone rather than face-to-face. This will avoid users having to make repeated visits to a clinic. I plan to investigate this new digital approach.Goals What is needed is a large study comparing this new digital programme with the conventional printed version of guided self-help. This will involve people with Binge Eating Disorder receiving one of these treatments (decided 'by chance'). This will let us measure which treatment is most helpful and which is better value for money. Before undertaking such a study, preliminary studies (described below) are needed to check whether the large study is likely to work and how best to do it. Individuals with Binge Eating Disorder have been involved in planning these studies.Plan First, I will examine the findings of all previous studies comparing digital interventions for Binge Eating Disorder with other treatments. If possible, I will group together the findings. I will also identify any aspects of each study that are of relevance to planning the future large study. Next, I will carry out discussions with three groups of people whose views will be central to the planning of the large study. These will be: i) people with Binge Eating Disorder; ii) health professionals who work in general practice; and iii) clinical professionals who specialise in the treatment of Binge Eating Disorder. I will ask them for their views on the planned main study. Lastly, I will carry out a small version of the large study. This will provide information on: how best to recruit people; how best to measure if treatment has worked; how much people use the two forms of treatment; and how to involve patients and the public in the main research study. Some of those participating in this 'feasibility' study will be interviewed to understand what it is like taking part. If the findings from the small study suggest that the large study will be of value, I will continue to involve patients and the public to help me to plan it, and will seek funds for it. These individuals will also play a crucial role in helping me to share the preliminary findings with researchers, professionals, patients and the public.Potential benefits to patients and the NHS Digitalising treatment for Binge Eating Disorder is likely to improve its effectiveness and cost-effectiveness, and it may also make it easier to access. If true, this will reduce the suffering of patients and costs to the NHS.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH