Title: Imagery Based Emotion Regulation for the treatment of Anxiety within Bipolar Disorder: A Feasibility Study
Funder: Department of Health and Social Care

Abstract: Anxiety is common in patients with bipolar disorder (BD) and persists between acute episodes of mania and depression. It is poorly understood and rarely adequately treated. Innovation in the treatment of anxiety within BD is called for given that it is associated with suicide, mood instability and relapse [4]. Patients with BD report experiencing intrusive anxious mental images which are hard to ignore and difficult to control [5,6]. Therefore a potentially modifiable mechanism underlying anxiety in BD is mental imagery [6,7,8]. Improving patients ability to regulate their emotional imagery provides a treatment target to reduce anxiety, mood instability and consequently relapse. We have developed a brief structured intervention, called Imagery Based Emotion Regulation (IBER). IBER is a mental imagery skills training programme aimed at improving the ability to regulate emotional images and thus reduce anxiety. Our recent case series [9] (mean number of sessions = 11.6) produced a pre-post effect size for anxiety reduction of 1.89, improved mood stability and a high level of engagement with treatment. The next step in the development of this novel intervention is to conduct a feasibility study in order to ascertain whether a full trial is indicated. We will conduct this study within two UK sites, recruiting sixty participants who will be randomised to receive either IBER or standard care. IBER consists of 12 individual sessions to be delivered within 4 months. Blind assessments will be conducted at baseline, and at 4 and 8 months post-randomisation. The proposed primary outcome is anxiety. Secondary outcomes are mood stability, depression, mania and cost-effectiveness. The study will take 26 months to complete, and consists of an initial setting up phase, followed by 12-months recruitment, a follow-up phase and a final phase of analysis and dissemination. We will assess trial acceptability by asking participants to respond to written open-ended questions about the length, time needed and acceptability of outcome measures, and their views about other trial procedures. We will explore intervention acceptability via service user informed semi-structured interviews. These will be conducted with 50% of the treatment arm (N=15), ensuring that we include in this sample people with a range of socio-demographic and clinical characteristics, as well as some participants who dropped out of treatment early. Given the feasibility objectives of this study, the focus of data analysis will be descriptive, and comprise of: (i) summarising participant flow across both sites using the CONSORT flow diagram, reporting mean recruitment and attrition rates (both intervention and study drop-outs) with 95% confidence intervals. (ii) mean and standard deviations of the main outcome (anxiety) for both study arms will be reported at baseline, 4 and 8-months. (iii) descriptive statistics will be produced for quantitative acceptability data, whilst qualitative data will be subject to thematic analysis. (iv) themes pertaining to treatment acceptability from the exit interviews will be described. The success of the feasibility study, and thus whether a full trial is indicated, will be assessed on the following criteria: (i) high levels of treatment satisfaction. (ii) no significant concerns about the acceptability and feasibility of the trial procedures. (iii) a recruitment rate of at least 80% of the target. (iv) follow up data at 8-months is available from at least 80% of participants. (v) a treatment drop-out rate of less than 20%.

Lay abstract: Bipolar disorder (BD), formerly known as manic depression, is associated with episodes of extreme high and low mood. Relapse rates are high and there is considerable room for improvement in the treatment of BD. People diagnosed with BD tend to suffer from anxiety. Being anxious is linked to people being more likely to have extreme mood swings and to attempt suicide. However, there are no treatments for anxiety for people in this group. We have been working on developing a new treatment for people diagnosed with BD and have discovered that the anxiety they experience is driven by having lots of emotional mental images that keep popping into their minds. On the back of this work, and together with service users diagnosed with BD, we have developed a new intervention called Imagery Based Emotion Regulation. It involves training people in skills to better manage their distressing mental images. An early version of this intervention was adapted based on feedback from those who received it and input from service-user focus groups. Imagery Based Emotion Regulation (IBER) involves up to 12 sessions within 4 months. We have tested our approach with 14 patients diagnosed with BD, and found large reductions in anxiety and improved mood stability. Patients reported that they found the skills easy to use. We plan to conduct a full trial to see whether IBER really works and is value for money. First, we need to conduct a smaller study to check that a big study would be acceptable to patients and achieveable within the planned time limits. This small study will recruit 60 people diagnosed with BD. Half will be offered IBER and half will get routine NHS care. We will carry out assessments over 8-months to help us decide if a big trial should be done.

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