Title: A study of the feasibility and effectiveness of the addition of Self Help Aid and Recovery guide for Eating Disorders (SHARED) to the treatment of anorexia nervosa.
Funder: Department of Health and Social Care

Abstract: Background Anorexia nervosa (AN) has a lifetime prevalence of 1% in females (4) and a 10-20% lifetime fatality rate (5). Early family intervention prevents AN from becoming entrenched (6, 7) but a subgroup have a persistent illness or develop the illness later when family interventions are less effective (8, 9) and outcomes are poor and treatment drop-out is high (10). The evidence-base for psychological treatment of adults with AN is extremely limited with only a handful of trials (n=9) (8,11-16). The recovery approach in which the expertise of patients themselves is included in management is a national mental health policy (17). The evidence base is limited but shows potential (18). The recovery approach has informed this novel intervention (Self Help Aid and Recovery guide for Eating Disorders: SHARED). It includes video and written material and email/phone guidance from recovered patients. This feasibility study will examine whether SHARED as an addition to treatment as usual improves engagement and symptom change and whether the recovery guidance for the initial 6 weeks adds benefit (without cost to guides themselves) to the self-help component of the intervention. Aims To examine whether SHARED can enhance treatment as usual for adults with anorexia nervosa. Primary Questions: 1) Does SHARED improve behavioural, symptomatic outcomes? 2) Does SHARED reduce drop-out from outpatient treatment? 3) Does the recovery guide component of the intervention increment acceptability and effectiveness? Secondary questions: What is the acceptability and uptake of the study amongst recovery guides, clinicians and patients? Are mediators (quality and fidelity of guidance, alliance) and moderators (stage of illness, motivation) of change consistent with theoretical predictions? What is the impact on wellbeing of recovery guides? Does the training and supervision enable the recovery guides provide high quality support? Can the intervention be improved by implementing feedback from recovery guides, clinicians and patients? Plan of investigation Patients with AN assigned to outpatient therapy are offered the opportunity to participate. Those consenting will be given mobile devices for use during the initial 6 weeks of treatment. Patients will receive treatment as usual (TAU) and will be randomised (stratified by centre) into one of three conditions: ecological momentary assessment (EMA) only; ecological momentary assessment plus SHARED delivered as guided self-help (SHAREDg); or ecological-momentary assessment plus SHARED delivered as pure self-help (SHAREDp). The primary outcome is the weight trajectory over a year and a quarterly summary symptom score. Secondary outcomes include process measures over 6 weeks and treatment adherence. Process measures (motivation/confidence, compliance, anxiety) will be obtained daily in the initial 6 weeks using EMA survey methodology. Other process measures (weight, attendance) will be recorded on a weekly basis over 6 months. Quality Assurance (QA): Transcripts/audio recordings of recovery guidance will be used for supervision and standardisation. Outcomes and feedback from patients and guides will inform the development of the intervention and the design of a full-scale trial.&ensp;&ensp;&ensp;&ensp;&ensp; Summary of the potential benefits to patients and the NHS There has been little research into the added benefit of self-help or the recovery approach for anorexia nervosa. Thus, the current study is exploratory. This project prepares the way for executing a definitive trial powered to determine the effectiveness of SHARED. Data on 6-month outcomes will be available for writing the protocol for the definitive trial at 2 years, with an expected trajectory for patient benefit evidence within 5-6 years. Our experience is that recovered patients are eager to help. The development of a standardised training and supervision programme with support for recovery guides will enable the recovery approach (if the cost/benefit ratio is favourable) to be applied to eating disorders.

Lay abstract: Anorexia nervosa (AN) has a lifetime prevalence of 1%, occurs predominantly in young women, and has a profound effect on the physical and psychosocial health of the individual and family. The cost of illness in the UK is over &pound;1.25 billion per year. Although family interventions for adolescents produce partial to full recovery in 50-80% after a year, there is uncertainty about treatment for adults in which recovery rates are less than 40%. Approximately 50% of cases persist for more than 6 years. Eating disorders produce secondary gains, the attainment of overvalued goals, emotional avoidance, and interpersonal attention which, combined with the secondary consequences, make change both difficult and unwanted. Self-help has been poorly investigated in anorexia nervosa, although it is effective in other forms of eating disorder. This study examines whether Self Help Aid and Recovery guide for Eating Disorders (SHARED) is a useful addition to standard treatment and whether guided self-help (SHAREDg: using recovered patients to provide support via email/phone in the initial 6 weeks of treatment) is superior to pure self-help (SHAREDp). The intervention is based on behaviour change theory and includes accessible, authentic video and written materials developed by recovered patients for use on mobile devices. We will examine whether the intervention can reduce symptoms and improve engagement in treatment. The potential for further enhancement of the intervention will be explored by measuring how change occurs, what component of the intervention is more effective and what patient/ therapy factors are relevant. Feedback from patients and recovery guides will be also be gathered. We will examine the impact of providing support on the health of the recovery guides. The overall aim is to optimise the content and the form of the intervention and knowledge about whether a larger study is justifiable and feasible.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH