Title: Specialist Psychotherapy with Emotion for Anorexia in Kent and Sussex (SPEAKS). An intervention development and multi-site feasibility study.
Funder: Health Education England

Abstract: Background. Anorexia nervosa (AN) is a severe mental illness with poor prognosis and the highest mortality rate of any psychiatric disorder. It is associated with high costs for both the person with AN and their families in terms of burden and suffering, as well as financially to the NHS and economy. NICE guidelines recommend psychotherapeutic interventions for adults with AN; yet outcomes are discouraging. No intervention is shown to be superior to a non-specific clinical control. Effect sizes of change are small to nil, placing the evidence base significantly behind other Axis-I disorders. Targeting unique factors associated with AN and developing innovative therapies is essential. Based on systematic reviews, I have developed a model of emotional experience and regulation as a putative maintenance factor in AN. I propose that earlier interventions developed for AN may have been impeded by a range of factors, including: (1) Lack of clear models; (2) Unsuccessful targeting (interventions not manipulating putative causal processes); (3) Too much complexity in interventions (interventions tackling too many factors in an everything is relevant' approach); (4) Overlooking unique needs of clinicians working with people with AN and consequential impacts upon therapeutic alliance and outcomes. Aims. I aim to develop a psychotherapeutic intervention targeting difficulties in emotional experience and regulation for adults with AN (Specialist Psychotherapy with Emotion for Anorexia in Kent and Sussex; SPEAKS). I will seek to overcome the above difficulties when developing SPEAKS by focusing on my clearly defined model of this core key putative maintaining process and by including consideration of therapist supervision needs. I will overcome issues of non-manipulation of variables by drawing heavily on stakeholder input throughout SPEAKS development and refinement. SPEAKS will be assessed in a mixed-methods feasibility study. Methods. Methods follow four phases. Phase One explores current understanding of facilitators and barriers to change in AN using two qualitative studies, with service users and clinicians, to understand their previous experience of therapy content and techniques. It will explore how to target emotions in clinical practice, alongside therapist effects/needs. Each qualitative study will recruit 12 participants, with data analysed using interpretative phenomenological analysis. Phase Two will integrate phase one data with the model and a series of focus groups with service users, carers, clinicians and NHS managers to develop the SPEAKS intervention, including a supervision model, described in a therapist guidebook. In Phase Three, a single-armed feasibility study across two specialist eating disorder (ED) services will recruit 60 consecutive referrals of adults with AN. All consenting participants will receive SPEAKS instead of psychotherapy as usual, with all other usual care provided. Participants will undergo assessments pre and post-intervention in a mixed-methods design. Post-intervention qualitative interview studies will be triangulated with quantitative clinical and emotion regulation change variables to assess validity and acceptability of SPEAKS. Feasibility will be further addressed using descriptive variables summarising recruitment and attrition rates and adherence to therapy/supervision models. Indication of effect sizes and economic evaluation will be achieved using clinical, intervention-specific and economic outcome measures collected pre- and post-intervention. Phase Four involves refinement of SPEAKS, revision of the guidebook and development of an application for a definitive RCT study. Potential benefits. There are no effective interventions for adults with AN: effect sizes of clinical change are small to nil. The illness is chronic with significant emotional, physical, psychological and financial burden. It is resource intensive to the NHS due to high rates of relapse, need for hospital admissions and physical, as well as psychological, health problems. Any intervention helping even a proportion of adults with AN would have significant implications for individuals, carers, the NHS and wider economy.

Lay abstract: Specialist Psychotherapy with Emotion for Anorexia in Kent and Sussex: the SPEAKS Study Anorexia nervosa is an eating disorder that causes people to lose weight and keep themselves at a very low weight by dieting, vomiting, using laxatives or excessively exercising. It affects up to four in 100 people at some point in their lifetime and has the highest mortality rate of any mental health disorder. People with anorexia often believe that they are fat or have a fear of becoming fat and they can also have depression, anxiety and low self-esteem. Anorexia is very distressing for the person with the illness and for their family. Being so thin can cause severe long-term physical difficulties, such as loss of muscle strength or bone strength. There are many reasons why people develop anorexia, but one common reason given by sufferers is that it helps them to feel in control of things and that thinking about food and calories can distract from difficult feelings or worrying thoughts and anxieties. It appears, therefore, that people can find their anorexia useful in managing their emotions, and that after having the illness for a while, they become scared to make changes, even if they would like to, as they do not know how they could cope without it. There has been a lot of recent research to support this idea. Psychological talking therapy is recognised by the National Institute for Health and Care Excellence (NICE) as the best option for treating anorexia in adults and it can lead to some improvements in weight and mood. At present there is no one particular type of therapy that stands out above any of the other talking therapies. The specific things that should be talked about, and how they should be managed in therapy, are unclear. We think that talking about feelings and working to find ways to manage them would be useful.This project will involve spending time talking to people with anorexia and their therapists to get an understanding of what they think has been helpful and unhelpful in therapy, particularly regarding when they have talked about emotions. This information will add to our understanding of anorexia as a way to avoid and manage feelings. It will enable us to develop a new psychological therapy that successfully targets these emotional difficulties and helps people to manage their feelings in ways other than by having anorexia. Developing the therapy will involve continued conversations with people with anorexia and those who have recovered, carers, therapists, and NHS managers in a series of groups to advise on what the therapy should include. The therapy will be tested in what is called a feasibility study. This will involve giving it to 60 people with anorexia who come to specialist eating disorder services within the NHS. They will have the new therapy instead of that normally offered, and all their other NHS care will remain the same. The goal is to see how feasible the new therapy is and how easily it can be put in practice. At the end of their therapy, we will ask the people with anorexia and their therapists what they thought of it, what was useful and what they would change about it. We will use all of this feedback to improve the therapy. If the feedback is positive, we will then run a larger study comparing this therapy against other therapies to see whether it is more effective. All of our findings will be communicated to policy makers within the NHS and to people with anorexia, their families and therapists via local NHS, support and charity groups.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH