Bipolar disorder is a life long condition which impacts on the individual, carers and wider society (NICE, 2006; Perlick, Hohenstein, Clarkin, Kaczynski, & Rosenheck, 2005). Bipolar disorder is also highly comorbid with anxiety disorders (93% lifetime (McIntyre, et al., 2006) and 32% current comorbid anxiety (Otto, et al., 2006)). Despite evidence for the effectiveness of psychological interventions for anxiety (NICE, 2004), there have been no systematic efforts to apply these in bipolar disorder.

Comorbid bipolar disorder and anxiety is associated with; poor treatment response (Feske, et al., 2000), increases in suicidality (Frank, et al., 2002), earlier age of onset of BD (Henry, et al., 2003), which is also associated with higher levels of suicidality (Perlis, et al., 2004), and greater risk of relapse (Otto, et al., 2006). Effective time-limited interventions for anxiety already exist and would therefore have the potential to improve a range of adverse outcomes in bipolar disorder.

Although there is an increasing literature documenting the effectiveness of cognitive behavioural therapy and other techniques in the treatment of bipolar disorder and in the treatment of anxiety, there has been little or no research of this type specifically targeted at individuals with a diagnosis of bipolar disorder and comorbid anxiety. This project aims to look at the experience of anxiety in bipolar disorder and develop a treatment which can be tested systematically with this client group. To do this the project was split into three phases.

Main research questions:

• Phase 1: to understand the experience of anxiety for individuals with bipolar disorder
• Phase 2: to develop a time limited intervention for anxiety in bipolar disorder based on the information gathered in phase 1
• Phase 3: to test the feasibility of implementing this intervention and its effectiveness for individuals with comorbid anxiety and bipolar disorder

Phase 1 will take a qualitative approach to understand more about the experience of anxiety in bipolar disorder. Semi-structured interviews will be used to identify the key themes associated with the impact of anxiety on individuals with bipolar disorder, how this comorbidity effects their lives and what help is needed and from whom in order to inform and develop an intervention with regards to anxiety in this client group.

Phase 2 will focus on developing a time limited intervention for anxiety in bipolar disorder. On the basis of the information collected in Phase 1 and evidence drawn from the literature and NICE guidelines for effective psychological approaches, an intervention which is designed specifically to target comorbid anxiety in bipolar disorder will be developed. This will be done through collaboration with multidisciplinary clinicians, programme applicants and service users in a series of treatment planning sessions. The output will be a therapy manual designed to address anxiety for people with bipolar disorder.

Phase 3 will be a treatment delivery and feasibility study. A randomised controlled trial will compare the feasibility and effectiveness of delivering the intervention developed in phase 2 versus treatment as usual. Consecutively eligible patients will be individually randomised to either intervention. Primary outcomes from this phase of the study will be feasibility of participant recruitment and consent to participate, adherence to protocol and retention within both arms across assessment, the intervention and follow-up at 6 months. Secondary outcomes are parameter estimates with respect to self-reported anxiety symptoms, subsyndromal bipolar symptoms, suicidality and recovery. Time to next bipolar episode will also be assessed. These findings will be used to provide preliminary indications of effect sizes to inform power calculations for a larger trial.

Setting

The study ran in Manchester, Lancashire, Merseyside, and Cumbria to ensure the generalisability of the findings.

Target population

Patients with bipolar 1 or 2 affective disorder who experience comorbid anxiety were participants in the study. In practice individuals with bipolar disorder who experience anxiety and who have a poorer response to treatment, increased bipolar and anxiety symptoms, and who are at increased risk of further relapse were the target for interventions aimed at preventing further relapse.