Title: Developing and Evaluating Psychological Therapy for Inter-Episode Symptoms of Bipolar Disorders
Funder: Department of Health and Social Care

Abstract: Bipolar Spectrum Disorders affect around 1 in 20 of the population across the lifespan and can incur considerable personal and economic costs. Ongoing bipolar symptoms outside of major episodes (interepisode bipolar symptoms: IEBS) are common and disabling, and are associated with worse outcomes for people with Bipolar Disorders. Despite this, we lack an evidence base for treating IEBS pharmacologically or psychologically. This endeavour is hampered by limitations in our measurement of therapy process and outcomes in this population.This programme of research aims to: i) develop a psychological intervention for people with IEBS that is ready to be evaluated in a phase III trial; ii) develop or identify the best means of measuring its outcomes and effect on key hypothesised mechanisms.These aims will be addressed within two workstreams. In workstream one, previous work by the applicant will be synthesised into a therapy protocol for people with IEBS, co-designed with clinicians and people with lived experience of Bipolar Disorder, and utilising an intervention mapping approach. Iteration of the protocol will be carried out in a two-phase, multiple-baseline case series (N=12). This will be followed by a randomised controlled feasibility trial across two sites (N=60, follow-up assessments at 2,6 and 12 months) to address uncertainties in trial feasibility and to further refine procedures for delivering the therapy and training and supervising therapists prior to application for funding for a definitive trial. Workstream two, conducted in parallel with workstream one, will innovate methods of measuring therapy outcome and effect upon key hypothesised targets. Cutting-edge analytical methods will be tested within existing datasets, and using data from workstream one. Techniques will be compared to one another in terms of their predictive validity, feasibility and acceptability. These methods will be applied alongside robust, traditional methods of outcome evaluation within workstream one. This programme of work will: i) provide information about the potential of this therapy for IEBS, an issue for which there are currently no gold-standard treatments. Subject to a future definitive trial, this therapy could then be recommended within NICE guidelines and provided nationally; ii) identify novel methods of assessing outcome and process which could be used in research but also in clinical practice to better evaluate existing services for this patient group and others.People with lived experience of Bipolar Disorder and clinicians will be involved from the outset of the project and will collaboratively shape the refinement of the intervention, the delivery of the programme and the strategy for dissemination and engagement.

Lay abstract: Bipolar Spectrum Disorders typically involve periods of depression, and periods of very high energy and mood (hypomania or mania). Bipolar Disorders are common, affecting around 1 in 20 people at some point in their lifetime. They can be very distressing and disruptive to the people who experience them, and for friends and relatives. Many people with these conditions have mood issues outside episodes of depression or mania. Often these issues include ongoing low mood, and/or frequent swings in mood or emotions. These are sometimes called 'inter-episode bipolar symptoms'. There are psychological (talking) therapies designed to help people with Bipolar Disorders, but these tend to be aimed at preventing the person from becoming really unwell, in other words from having a relapse of depression or mania, or they are aimed at helping people recover from a period of depression. There is no universally accepted talking therapy for helping people who have ongoing low mood or mood swings in between full episodes. This is despite the fact that these are common and distressing, people ask for help with them, and managing ongoing symptoms may make a relapse of mania or depression less likely. The aim of this research programme is to develop such a talking therapy. Along with people with lived experience of Bipolar Disorders I will integrate and adapt two similar talking therapies we have previously developed for mood swings and for bipolar depression. After developing the new therapy it will be tested initially in a small number of people, to help improve it based on feedback from the patients and therapists. There will then be a small clinical trial, in which half of the participants will have the new therapy and half will not. The overall goal is to develop a therapy that is promising in terms of being ready to test in a large clinical trial. This would tell us whether it is worth the NHS rolling it out across the country. Alongside this, I will develop better ways of knowing whether therapy 'works' for people with Bipolar Disorders. Currently, this is done by asking people to describe their mood or wellbeing at one point in time. however this may not reflect changes in people's mood swings over time, and it does not take into account that people may have different preferences about what they would like to improve. For example, some people may prioritise feeling less depressed or anxious, whilst others may prioritise feeling better able to cope with their mood swings. As part of the therapy development work, I will include some new ways of asking people about their mood and what is important to them, as well as new ways of combining information from different questionnaires. With help from people who experience Bipolar Disorders I will also develop new ways of looking at how these sorts of therapies work, so that we can tell earlier if the therapy is working the way it should. Promising methods can then be used in future research and NHS care. In order to maximise the usefulness of this research to patients, their families and the NHS, people with personal experience of Bipolar Disorders will be involved at all stages of the research. The research findings will be shared with the public through traditional and online media and mental health charities, as well as with researchers, clinicians and those who took part.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH