Title: Cognitive behavioural therapy in comparison to treatment as usual in adults at high risk of developing bipolar disorder (Bipolar At Risk): A feasibility study
Funder: Department of Health and Social Care

Abstract: Background: Research has demonstrated the ability to identify and treat individuals at high risk of developing psychosis and more recently that it is possible to utilise a similar strategy to identify people who have an emergent risk of Bipolar Disorder (BD). BD is a severe, recurrent and disabling condition with significant consequences for individuals, families and society. The cost of BD in the UK for 2007 was estimated at &pound;5.2 billion and projected to reach &pound;8.2 billion per year by 2026. Interventions during the early phase may reduce these costs. Based on the work from psychosis, criteria have been established to identify individuals considered to be at high risk for developing BD (Bipolar At Risk). Identifying this group and offering an intervention may reduce transition to a full expression of BD and offer the possibility of prevention. We have conducted a single-arm feasibility study of 25 sessions of cognitive behavioural therapy (CBT) with individuals meeting Bipolar At Risk (BAR) criteria. The treatment was associated with significant improvements in depression (p=0.047) and mania symptoms (p=0.025) and encouraging within-subjects effect sizes (depression: 1.09 at end of treatment, 1.61 at 6 month follow-up and for mania: 1.28 at end of treatment and 1.13 at follow-up). However, these are likely overestimates due to potential bias resulting from lack of blinding or a control-group. Aims: The overall aim is to identify people who are considered to be at high risk of developing Bipolar Disorder (BD), and to investigate whether a psychological intervention is an acceptable, feasible and potentially effective treatment option. In this study we will apply a CBT model for use in BD which has shown utility for use within a group of people considered to be at high risk of developing BD. We will also carry out qualitative interviews to understand individuals experiences of therapy and trial participation as well as family members/relatives unique experiences. Method/Plan: This feasibility study will apply a randomised design to test the acceptability of a psychological intervention (CBT) in people considered to be at high risk of developing BD (Bipolar At Risk). 76 Individuals will be randomised to one of two conditions, in the treatment as usual group they will be monitored for 1 year to assess levels of transition to full BD and in the treatment group they will be monitored for one year plus given a CBT intervention aimed at minimising transition to BD, reducing distress and increasing quality of life. Assessments will be carried out at baseline, 6 and 12 month follow-up. We will also conduct a nested qualitative interview study (n=15-20) with a purposive sub-sample and their associated family members/relatives (n=15-20) to understand experiences and acceptability of the therapy and research procedures. Clinical Implications: If people meeting Bipolar At Risk (BAR) criteria are detected then interventions aimed at reducing these symptoms and associated distress may reduce the chance of a future full blown episode of BD. It is widely recognised that developing strategies for working with people in the earliest stages of their mental health problems is an important step forward for mental health services. Early intervention for psychosis services have been comprehensively established throughout England. Extending the early intervention paradigm to other mental health problems could be seen as a major priority but evidence is required to support this approach, both for detection and intervention strategies. The department of health emphasises the importance of extending services into the community and developing interventions with a focus on health promotion/prevention. Finally, Improving Access to Psychological Therapies (IAPT) is being extended to those with severe and enduring mental illness, which could benefit from this research.

Lay abstract: Bipolar Disorder (BD) affects around 1% of the population. 1.14 million people met criteria for this condition in 2007. The World Health Organisation has identified BD as one of the main reasons for loss of life and health in 15&ndash;44 year olds, with a diagnosis of BD increasing the rate of suicide above the general population rate by 20-30 times. There is poor recognition of the disorder, especially in the early stages. People often experience misdiagnosis which causes frustration and disenchantment with services. Misdiagnosis can also lead to incorrect treatment which can make people's difficulties worse. BD also has financial costs; it is thought that the cost of BD in the UK for 2007 was &pound;5.2 billion and likely to rise to &pound;8.2 billion per year by 2026. People who experience symptoms of high and low mood and meet criteria for Bipolar At Risk (BAR) are considered to be at high risk of developing a full episode of BD. If these individuals are detected then interventions aimed at reducing these symptoms and associated distress may reduce the chance of a future full blown episode of BD. Early intervention for psychosis services have been successfully established throughout England. Extending early intervention to other mental health problems such as BD would be a major step forward in preventing long-term problems and their associated distress, disability and financial burden. The importance of developing interventions with a focus on health promotion and preventative interventions has long been recognised. However, evidence is required to test what treatments might best help this group. This study provides an investigation of a specific psychological intervention. This work fits with recent policy developments such as the Improving Access to Psychological Therapies Programme for those with severe and enduring mental illness.

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