HeartRater:Clinical. Optimizing ADIE therapy for the treatment of anxiety in underserved populations. Follow up to Outline proposal (ref MR/X005755/1)

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Anxiety costs the UK over £8.9 billion/yr. It is one of the most common mental illnesses and an important, frequent symptom across many psychiatric conditions: in the UK, anxiety contributes to 1 in 5 GP consultations. Access to targeted therapy for anxiety is limited, yet 32% of the 1.7M/year individuals referred to Improving Access to Psychological Therapies (IAPT) services do not take up therapy. These individuals include autistic people and those with complex physical conditions such as joint hypermobility. Our Patient and Public Involvement (PPI) panels identified difficulty engaging in standard talking therapies to be a key a reason for people declining offers of IAPT therapy. Our novel therapy for anxiety, Aligning Dimensions of Interoceptive Experience (ADIE), targets bodily aspects of anxiety and is based on over a decade of our scientific and clinical research on the contribution of interoception (signalling and perception of bodily changes) in emotion and its disorders. Our aim is to optimize ADIE so that it can ultimately be implemented in NHS, particularly for those underserved by the current available options. Interoception describes the internal sense of what is happening in the body. Our previous work has shown differences in interoception related to anxiety, particularly in autistic individuals and those with complex physical health problems. ADIE is an interoceptive training protocol delivered over 6 sessions. The training combines real time measurement of cardiac physiology (heartbeats) with a set of tailored computerised training tasks. A randomised clinical trial (RCT; N=121) demonstrated ADIE's effectiveness in improving anxiety in autistic adults. This study was run in-person by trained researchers using an optical cardiac sensor linked to a laptop computer. A more recent feasibility RCT (N=40) successfully delivered ADIE to patients with complex physical conditions in their homes, via a new digital platform HeartRater:Clinical (using a computer tablet + heartbeat sensor + software) with online therapist guidance. This project aims to improve the accessibility, inclusivity, and engagement of ADIE as a therapy for anxiety in adults, notably those who do not benefit from standard treatments, such as autistic adults and those with physical health problems. With PPI, this project will co-produce an optimized version of HeartRater:Clinical to deliver ADIE as a standalone software-guided therapy for patients referred to IAPT services: Firstly, ECG will replace optical heartbeat sensors to improve signal reliability in patients with poor peripheral circulation and/or darker skin. Secondly, the user-interface will be optimized for software-guided administration, with gamification to enhance engagement. Next, a Phase 2a clinical trial will test proof-of-concept feasibility of HeartRater:Clinical/ADIE as a 'low intensity' self-administered, software-guided standalone therapy, relative to 'high intensity' therapist-guided use, with feasibility, clinical, qualitative and evaluation process outcomes.Finally, we will pave the way for implementing HeartRater:Clinical in the NHS. We will secure intellectual property rights, and with support from expert partners, a business plan will map pathways for commercialisation, including further funded research (e.g. Health Technology Assessment (HTA) NHS RCT) with health economic evaluation.