A randomised controlled trial of time limited CBT informed psychological therapy for anxiety in bipolar disorder

BACKGROUND: Anxiety comorbidity is common in bipolar disorder and is associated with worse treatment outcomes, greater risk of self harm, suicide and substance misuse. To date however there have been no psychological interventions specifically designed to address this problem. The primary objective of this trial is to establish the acceptability and feasibility of a new integrated intervention for anxiety in bipolar disorder designed in collaboration with individuals with personal experience of both problems. METHODS AND DESIGN: Single blind randomised controlled trials to assess the feasibility and acceptability of a time limited CBT informed psychological intervention for anxiety in bipolar disorder (AIBD) compared with treatment as usual. Participants will be recruited from across the North West of England from specialist mental health services and through primary care and self referral. The primary outcome of the study is the feasibility and acceptability of AIBD assessed by recruitment to target and retention to follow-up, as well as absence of untoward incidents associated with AIBD. We will also estimate the effect size of the impact of the intervention on anxiety and mood outcomes, as well as calculate preliminary estimates of cost-effectiveness and investigate potential mechanisms for this (stigma, self appraisal and stability of social rhythms). DISCUSSION: This is the first trial of an integrated intervention for anxiety in bipolar disorder. It is of interest to researchers involved in the development of new therapies for bipolar disorder as well as indicating the wider potential for evaluating approaches to the treatment of comorbidity in severe mental illness. TRIAL REGISTRATION NUMBER: ISRCTN84288072