Title: 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
Funder: Department of Health and Social Care

Abstract: 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 < 18.5, Age > 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.

Lay abstract: The aim of this study is to improve treatment for patients with severe anorexia nervosa and to help their carers and families. The care of patients in the early stage of the illness (within a year of onset) has been transformed by research which has found that: (1) involving the family is critical and (2) outcomes from short hospital admissions (goal: medical stabilisation) are superior to a longer stay with an admission goal of normal weight restoration (the traditional treatment ethos). However, there is uncertainty about the management of the subgroup (25% -50% of total) who fail to respond to an early intervention or who present later. These young adults develop severe malnutrition and have repeated and protracted hospital admissions. The majority of these live with or are dependent on their family as their work and social adjustment is impaired. NHS statistics indicate that the length of stay and the mortality in the year post-admission is higher in this patient group than for other psychiatric conditions. The poor response to current treatment resulted in two cases being referred to the courts. The divergent verdicts about continuing treatment exemplifies the uncertainty about the effectiveness of current treatment. Nevertheless these patients have the potential for full recovery. In our programme grant, we found poor overall results in current UK practice. There is a large variation in policy and practice relating to admission and discharge medical risk, and length of stay at each centre. Overall, patients were admitted at a BMI of 14 which is substantially below the WHO guidelines for severe malnutrition (BMI 16) and below the range recommended in guidelines from other countries. Most patients remained underweight when discharged. The annual NHS England cost of illness analysis ranged from £45 million (75% driven by inpatient treatment) to £230 million (60% absorbed by the value of ‘years of life lost’)). We conducted two multicentre pilot studies (set in the majority of NHS England specialised inpatient centres) testing whether new interventions could improve the outcome for patients in this late stage of illness. In Study 1 (CASIS) we examined the addition of care-giving skills for families and in Study 2 (iMANTRA) we examined the addition self management materials for patients. Both of these low-cost interventions (consisting of written information and email guidance) reduced the relapse rate from a third in the treatment as usual (TAU) arm to a fifth in the TAU plus intervention arm and patient health was improved. Moreover the burden and quality of life for carers also improved when families were given caregiving skills. These findings are encouraging. We have shown that these approaches are feasible, acceptable and effective and so a larger definitive study is warranted. The current multicentre study is similar in design to the previous studies but with improvements from the lessons learned. We anticipate that the combined intervention (for individual and family) will provide a synergistic effect. Small charities have supported us to add greater appeal and impact to the multimedia training materials. The delivery is informed by the recovery approach whereby the social resource of people with experience of a mental illness is used to help others. We will measure outcomes which are sensitive and relevant to patients and their families.

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