Title: Shortening Duration of Untreated Illness in First Episode Eating Disorders: Development and Randomised Controlled Feasibility Trial of a Smart-Phone Friendly Multi-Modal Decision Making Tool (FREED-M) to Improve Help-Seeking
Funder: Department of Health and Social Care

Abstract: Research question: In young people with a first episode of an eating disorder (ED), is it feasible to improve treatment/change motivation and help-seeking and shorten the time between a person first developing symptoms and starting treatment, i.e. the duration of untreated ED (DUED), through a smartphone-friendly online decision-making tool? Background: Early intervention for EDs improves outcomes. A key objective for early intervention is shortening DUED. DUED has patient-related (lack of problem recognition or help-seeking) and service-related (waiting lists) components. We previously showed that service-related delays can be overcome using a novel rapid early intervention service for EDs. We now aim to improve help-seeking. Aims: (a) To develop a smartphone-friendly multi-modal online decision-making tool for young people with a first episode ED to increase motivation for treatment/change, help-seeking from primary care and attendance of specialist assessment/treatment and thus reduce DUED. (b) To carry out a feasibility randomised controlled trial (RCT) comparing the intervention to a credible control intervention. Objectives: The objectives of the proposed trial are to establish/estimate: (a) attrition rates at follow-up (primary feasibility outcome) (b) participant recruitment from different sources (c) young people s willingness to be randomised (d) intervention effect sizes and standard deviations for outcomes to inform the sample size calculation for a large-scale RCT (e) the intervention s acceptability, uptake and completion rates (f) stakeholders (young people, education/primary care staff, parents/carers) views on the intervention, optimal delivery pathways and study procedures. Methods: We will co-design a smart-phone friendly decision-making tool for young people with early stage EDs. This tool aims to improve knowledge about EDs and motivation to seek treatment by giving psychoeducation via short animations, personalised feedback on symptoms, and highlighting steps towards getting help. If help is sought, the tool will direct users to the appropriate setting. Early steps towards change or recovery will be encouraged. We will carry out an RCT comparing the intervention with a control group, in which people are sign-posted to resources on ED charity websites. We will recruit 116 participants (young people, aged 16-25, with a first episode of an ED) from primary care, schools and universities. Online assessments will be carried out at baseline, end of treatment and follow-up (weeks 0, 4 and 12 post-randomisation). Outcomes will include uptake of GP appointment, ED-referral/treatment and DUED, motivation to change, mental health literacy and ED recovery self-efficacy, ED symptoms, mood and social functioning. Additionally, we will carry out a qualitative evaluation of stakeholders views of the intervention and optimal routes for its delivery. Setting: This trial will be conducted in areas where the local ED service is part of our network of services delivering early intervention for EDs (FREED Network). Timeline: We will develop and beta-test the intervention during months 0-12. We will carry out the feasibility trial and write-up during months 13-24. Impact and dissemination: This novel intervention has the potential for substantially reducing DUED. If successful, and after carrying out a large scale trial, we would disseminate the intervention widely in National Health Service (NHS), community and education settings.

Lay abstract: Aims and objectives: The aim of this study is to develop and test a smartphone-friendly, online intervention for young people, who have recently developed an eating disorder (ED), called FREED-M (First Episode Rapid Early Intervention for EDs&ndash;Mobile). This intervention aims to increase young people s understanding of their illness and to raise their motivation to seek treatment. It will do this by giving them information about EDs, personalised feedback on their symptoms, and practical steps on how to seek help. Before we conduct a large evaluation, we will first conduct a feasibility study to explore how young people find this new intervention, and to gather the data we would need to carry out the larger evaluation. Background to the research: Early intervention (getting help quickly when a problem starts) gives young people the best chance to recover from EDs. An important focus of early intervention is to shorten the time between a person first developing symptoms and starting treatment (duration of untreated eating disorder; DUED). DUED has several parts. Some are patient-related (e.g., not knowing there is a problem, not asking for help) and others are service-related (e.g., waiting lists). We have previously shown that service-related delays can successfully be overcome by changing the way services are run (using a novel first episode rapid early intervention service for EDs, known as FREED). We now want to tackle the help-seeking component of DUED. Design and methods: We will randomly allocate young people to either receive our new intervention (FREED-M), or to be directed to existing online resources for people with EDs. We will recruit 116 young people, aged 16-25, with a first episode of an ED to take part in this study by advertising the study in GP practices, schools and universities across England. We will assess how long it takes young people to seek and receive help. We will also collect information about participants ED symptoms, mood, social life and motivation to change three times over 12 weeks. Our main outcome for this study will be the percentage of young people who complete the study (i.e., do the final assessments). Patient and public involvement: Three young people with an ED have read, commented on and supported this application. We will develop the intervention jointly with young people with EDs and other stakeholders, which is an approach we have successfully used before. Two young people will be involved in study design (e.g., recruitment, writing study information), trial steering group, writing up results, dissemination and planning of the larger study. Dissemination: We will disseminate our findings through conferences, scientific papers, and media/social media, as well as patient, school and university organisations, and our early intervention network.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH