Title: Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): A randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change (BART II)
Funder: Medical Research Council

Abstract: Bipolar Disorder (BD) affects around 1-3% of the population. 1.14 million people met criteria for this condition in 2007 and this is expected to rise to 1.23 million by 2026. The World Health Organisation says BD is one of the main reasons for loss of life and health in 15–44 year olds, and BD increases the rate of suicide above the general population by 20-30 times. It is poorly recognised, especially in the early stages. People often experience misdiagnosis which causes frustration and disengagement with services. This can lead to incorrect treatment which can make peoples’ difficulties worse. BD also has financial costs; the approximate cost of BD in the UK for 2007 was £5.2 billion and this is likely to rise to £8.2 billion per year by 2026._x000D_ _x000D_ People who experience 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 identified early, then interventions aimed at reducing the symptoms and their distress may reduce the chance of a future episode of BD. Early intervention for psychosis services have been set up throughout England. Extending early intervention to other mental health problems such as BD would be a big step forward in preventing long-term problems, distress, disability and financial costs._x000D_ _x000D_ Developing interventions which focus on health promotion and prevention has long been recognised. Our team have conducted a successful study to see whether a psychological therapy (cognitive behavioural therapy, CBT) can be given to individuals who meet criteria for Bipolar at risk (BAR), and whether it would be a potentially useful treatment. Our pilot work showed that CBT (CBT-BAR) is an acceptable (as shown by feedback from people who took part) and feasible treatment option (as shown by people agreeing to take part and attending the therapy sessions) for people meeting BAR criteria. We successfully recruited 76 people to take part in the study, provided therapy to those allocated to therapy and followed up over 85% of people 12 months later. The study showed promising findings e.g. improved mood, functioning and those who took part were positive about their experiences and the impact it had on their life._x000D_ _x000D_ We would now like to repeat this study to understand if this therapy works in a larger group of people, across 5 different sites in the UK. We will conduct a large randomised controlled trial comparing CBT-BAR to the usual treatment for individuals meeting BAR criteria to study the ability of an intervention (CBT-BAR) to improve mood swings by changing important psychological processes. As this will be a randomised controlled trial, this means that half of people who agree to take part will receive CBT and half will not receive CBT but their usual treatment will not be affected. This will test whether CBT is an effective and helpful treatment option for this group. This study will help us see if changes through CBT-BAR make a difference in peoples’ distressing mood swings and other outcomes in the lives of young people._x000D_ _x000D_ Engagement with people with lived experience and families will be conducted at meetings throughout the duration of the trial, allowing opinions to be shared and expert opinions to be discussed. Results will be communicated through journal articles, presentations and feedback meetings for participants.

Lay abstract: Background: Research has demonstrated the ability to identify and treat individuals at high risk of developing psychosis and that it is possible to utilise a similar strategy to identify people who have an emergent risk of Bipolar Disorder (BD). BD affects around 1-3% of the population with 1.14 million meeting criteria for BD in 2007, expected to rise to 1.23 million by 2026. The World Health Organisation states BD is one of the main reasons for loss of life and health in 15–44 year olds, and BD increases suicide rates above the general population by 20-30 times. The cost of BD in 2007 was estimated at £5.2 billion, projected to reach £8.2 billion by 2026. Interventions during the early phase may reduce these costs. Criteria have been established to identify individuals considered to be at high risk for developing BD (Bipolar At Risk, BAR). Offering this group an intervention may provide the possibility of prevention. Our team have conducted a successful study to see whether a psychological therapy (cognitive behavioural therapy, CBT) can be a useful treatment for individuals who meet BAR criteria. Recruiting 76 people for our pilot work, we demonstrated excellent acceptability/feasibility data. Participants in the CBT arm significantly improved compared to those who received treatment as usual (TAU) on measures of mood and functioning at 6 and 12 months. Risk of conversion to mania/hypomania was reduced for those randomly allocated to CBT. Evaluating efficacy and the mechanisms by which this treatment works is the next step._x000D_ _x000D_ Aims and Objectives: We aim to evaluate the efficacy of a specific intervention (CBT-BAR) in a 2-armed multicentre randomised controlled trial comparing CBT-BAR plus TAU versus TAU only for BAR individuals. We will examine whether improvement in mood swings is mediated via key psychological processes: the reduction of extreme positive and negative appraisals of internal states and subsequent behaviours used to control mood. Our objective is to recruit 338 participants in 5 NHS sites in England randomising eligible (BAR) participants to receive our treatment condition (CBT-BAR plus TAU) or control condition (TAU alone)._x000D_ _x000D_ Methods: Using a multicentre rater-blinded randomised controlled trial with 2 parallel arms we will compare CBT-BAR + TAU to TAU alone. Participants will be recruited from NHS in 5 sites in the UK; Greater Manchester, Lancashire, Sheffield, Birmingham, and Norfolk & Suffolk and randomised to one of the two arms. Outcome and mediational variables will be collected at baseline, 4 months (in treatment), 6 months (after therapy cessation), and at 12 months. Qualitative work will examine the perceived mechanisms of change and implementation for NHS patients._x000D_ _x000D_ Impact and dissemination: Trial data will impact on the development of an evidence-based treatment for young people meeting BAR criteria deliverable within the NHS, including valuable data on the mechanisms which are effective treatment targets in reduction of risk to long-term distressing mood swings. This research will provide an opportunity to extend early intervention to BD as a major step forward in preventing long-term problems, distress, disability and financial costs. Dissemination will be via peer review publications, conference and network presentations and feedback sessions for participants. Our CBT-BAR manual plus training materials will be provided to facilitate effective uptake, implementation and sustainability in the NHS.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH