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)

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. 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). 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. 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.