A multicentre, investigator-blinded randomised, 12 month, parallel group, superiority study to examine whether the addition of shared patient and family aftercare improves patient and carer wellbeing following inpatient treatment for anorexia nervosa

Design: This project builds on two pilot studies from RP-PG-1209-10092 which examined two forms of aftercare following inpatient treatment for anorexia nervosa: one programme was for patients themselves (Maudsley Model of Treatment for Adults with Anorexia Nervosa iMANTRA) and the other was an indirect approach offered via a skills training programme for caregivers (Experienced Caregivers Helping Others; ECHO). Both of these pilot studies found benefits over treatment as usual. Aim: The aim of the current study is to examine the clinical effectiveness and cost-effectiveness of a guided-self help intervention in a parallel group, superiority randomised control design with allocation of inpatients with anorexia nervosa and their carers to treatment as usual, with, or without, the “ECHOMANTRA” intervention. We will measure patients’ and carers’ well-being at repeated 3-month intervals over 18 months following admission using multi-method assessment techniques. In addition, we will measure service use, costs, and the role of prospective mediators and moderators of clinical outcomes. Setting: The majority of NHS (n=15) and independent (n=10) eating disorder inpatient centres in the UK. Target Population: People with anorexia nervosa (BMI 17) admitted for inpatient care and their carers. Design: We have chosen a 2-arm rather than a factorial design for theoretical and pragmatic reasons. Health Technology: The intervention is based on the empirically-supported cognitive interpersonal model of anorexia nervosa (1, 3) and involves guided self-help for patients in combination with guidance for joint carer/patient management. Guidance will be delivered by health professionals with the aim of favouring behaviour change in both patients and carers by helping participants to set-up small goals and try out behavioural experiments. The engagement phase of the intervention begins after admission when patients and carers access the materials with guidance through a website, IESO (previously PsychologyOnline), which is also used as an administrative tool. The carer DVD and patient recovery tips "vodcasts" (video podcasts) illustrate change and strategies for social support. After discharge, patients are guided through implementation in the home environment (10 individual, real-time, text-based sessions and 10 joint sessions with their carers via Skype/facetime). Measurement of costs and outcome: We will measure both patient and caregiver outcomes at 3-monthly intervals over the year following admission. The primary outcome for patients is mood and stress (DASS) at 12 months. Secondary patient outcomes include body mass index, psychopathology, social functioning and quality of life at 12 months and burden, stress, mood and quality of life at 12 months for carers. The main perspective for the economic evaluation is that of the health care system. Sample size: A sample size of N = 380 dyads will be sufficient to determine clinically significant improvements under ECHOMANTRA compared to TAU and recruitment is feasible in 30 months. This calculation is based on the effect sizes found in the pilot studies. Timetables: Set-up (6m) and Patient Recruitment (6-36m). At 48-50m, the follow-up period of 12 months will be completed and at 48-60m, data cleaning, analysis and preparation of reports will occur. Expertise: The team (clinicians, statisticians, health economist and people with PPI experience) worked together on the programme grant. We will also use the Experience-based co-design (EBCD) methodology to broaden the reach and engagement with the ECHOMANTRA intervention materials. EBCD brings together patients, carers and practitioners to evaluate existing resources and co-design treatment improvement initiatives. We will recruit three PPI leads with lived experience of eating disorders or experience of caring for an individual with an eating disorder, and links to the voluntary sector and/or professional organisations. We will deliver four EBCD workshops involving “co-designers” including carers, patients and healthcare professionals (N=100) selected through purposive sampling (e.g., to include people of different sexes, gender identities, ethnicity, duration of illness, and from more diverse geographic locations). The overall aims of the workshops are to understand (1) how to further develop materials to meet the needs of more marginalised groups, and (2) how to best integrate and disseminate materials. Drawing on Clark Bryan et al’s (in preparation) analysis of participants’ experiences of TRIANGLE, the four workshops will cover the following themes: (1) How to engage and meet the needs of a diverse population, (2) How, when, and what to include regarding social and peer support, (3) Developing resources for people at different stages of recovery, and (4) Using remote support based on what we have learnt from the COVID-19 pandemic. Throughout the workshops, participants will evaluate the relevance of our existing materials (considering factors such as the age and sex of the patient and their supporters, eating disorder symptoms, stage of illness, ethnicity/background, sexuality and gender identity of those using the materials) and to co-design resources relevant to a broad group of patients and their loved ones.