Title: The clinical and cost effectiveness of adapted Dialectical Behaviour Therapy (DBT) for Bipolar Mood Instability in primary care (ThrIVe-B programme): A feasibility study.
Funder: Department of Health and Social Care

Abstract: Background: Bipolar Spectrum Disorders (BDs: Bipolar I,II, other specified Bipolar Disorder, Cyclothymic Disorder) result in significant personal and societal costs2. Around half of people with BDs experience ongoing, frequent fluctuations in mood across days and weeks (Bipolar Mood Instability: BPMI) 3. BPMI includes, but is not limited to, those with Cyclothymic Disorder and can be present in someone with Bipolar I or II Disorder, in addition to full mood episodes. There is a clear need for effective interventions for BPMI: it is associated with significant distress and impairment in its own right, and risk of developing a full mood episode. There is no established pharmacological or psychological treatment strategy for BPMI and few treatment trials of either approach that focus primarily upon BPMI, despite psychological therapies for individuals with BDs being a national priority4. Existing NICE recommended therapies for BDs, including Cognitive Behavioural Therapy, focus upon ameliorating depression or preventing major mood episodes,5 not upon addressing BPMI. In response we have adapted an existing psychological therapy that is specifically designed to address mood instability in personality disorders (Dialectical behaviour therapy: DBT)6 for BPMI. Our approach (ThrIVe-B programme) has been designed with patient and clinicians, is informed by theory, has preliminary data supporting its feasibility and acceptability and is configured to maximise likely cost effectiveness. Aim: To assess the feasibility and acceptability of a future definitive randomised controlled trial (RCT) evaluating the clinical and cost effectiveness of a psychological therapy programme (ThrIVe-B) for adults with frequent bipolar mood swings. Plan of Investigation: Across two sites (Devon/Exeter and Cumbria/Lancaster) we will randomise 48 individuals to Treatment as Usual (TAU) or Treatment as Usual plus the ThrIVe-B programme (TAU+ThrIVe-B). Participants will be adults with a diagnosis of Bipolar or Cyclothymic Disorder and current bipolar mood instability, who are not currently in an episode of mania of depression. Participants allocated to TAU+ThrIVe-B will receive 16 group treatment sessions and up to 8 concurrent individual sessions, plus a purpose-built smartphone application that supports the therapy. Data will be collected on acceptability of the therapy and trial, symptom level and variability, quality of life and personal recovery and variables representing hypothesised process of change (reduced mood-related impulsivity and avoidance, increased emotional acceptance, improved emotional problem solving and interpersonal functioning, increased stability of routine). Follow up points will be at 3, 6, 9 and 15 months post randomisation, with 9 months as the proposed primary end point. As a feasibility study the focus of data analysis will be descriptive and will include evaluation of candidate primary outcome and health economic variables. Evaluation will also address whether or not the trial has met our pre-specified continuation criteria for progression to a future definitive RCT. Potential Benefits to Patients and the NHS: Should this evaluation indicate progress to the definitive trial stage, the research team plan to submit an application for definitive trial funding by the end of 2019. This definitive trial will allow us to determine if ThrIVe-B is a clinically and cost-effective therapy that can be recommended to NICE as a new treatment option for a client group for whom there is currently very little evidence-based therapy. This would represent a significant enhancement to patient choice, health and wellbeing. In the short to medium term the current study will result in further knowledge and awareness of this understudied yet common aspect of Bipolar Disorder. The smartphone application is flexible in terms of its possible therapeutic uses and as a co-designed , purpose built, freely available piece of software it could be used to compliment a range of other interventions.

Lay abstract: Bipolar Spectrum Disorders (BDs) include Bipolar Disorder and Cyclothymic Disorder and are fairly common, affecting around 3-4% of people in the U.K. They are very costly, both personally and economically. BDs often involve episodes of depression and mania lasting for weeks or months. In addition, or alternatively, around half of people with BDs have more frequent swings in mood lasting for hours or days. These frequent mood swings impact on day-to-day coping and increase the chances of additional mental health conditions and full mania or depression. People with BDs often want psychological treatments, but so far these have focused mainly on the full bipolar episodes rather than mood swings. A treatment that helps people with BDs to manage frequent mood swings could improve day-to-day mental health, and may even reduce the chance of a full episode developing. With input from patients and clinicians we have developed the ThrIVe-B programme to target frequent bipolar mood swings and the difficulties they can cause. The ThrIVe-B programme involves a course of 16 two hour weekly group sessions, with printed course notes, 8 individual therapy sessions and use of a supporting smartphone application. The course notes can be personalised and provide longer term support. In addition there is a reunion" top-up session three months after the programme has ended. Currently we are proposing a small feasibility study to help plan for a large clinical trial. Across two locations (Devon and Cumbria) 48 people with frequent bipolar mood swings will be recruited and allocated at random to receive either their usual treatment or usual treatment plus the ThrIVe-B programme. The participants will complete regular questionnaires and interviews. The results will help to plan for a full clinical trial that will ultimately test whether ThrIVe-B is effective and provides good value for money."

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