Development of an accessible Cognitive Behavioral Therapy digital therapeutic for individuals with Long COVID - PROJECT SUMMARY The over 100 million cases of COVID-19 that have occurred in the US since 2019 have spurred a ‘pandemic within a pandemic’ as up to 70% of COVID survivors experience long-term medical conditions and 10-20% develop post-acute sequelae of SARS-CoV-2 infection (PASC) or ‘Long COVID’. Strikingly, 6 weeks after diagnosis, 30% of Long COVID patients require assistance for daily activities and over 75% report impaired ability to work. Symptoms of Long COVID include both physical and psychological impairments. 30% of COVID patients develop vision issues that can persist into Long COVID, and over two-thirds of Long COVID patients present with serious mental health symptoms. Thus, there is a critical need for accessible digital mental health interventions to serve the growing population of Long COVID patients. Cognitive behavioral therapies (CBTs) are a known effective treatment for depression, anxiety and other mental health disorders, and the rise of digital health offers a new opportunity to provide large-scale, cost-effective, accessible CBT services to patients in populations where access to mental health care is difficult to obtain. In the case of Long COVID, access to effective mental health care is complicated by the heterogenous nature of the population and a current lack of consensus guidelines for management of Long COVID and related mental health impacts. Despite the enormous negative impact of Long COVID on mental health, patients describe gaining access to appropriately personalized treatment as ‘complex, difficult, and exhausting’. A readily accessible, highly personalized, and cost-effective means of CBT digital health services would be ideally positioned to meet the critical and rapidly growing mental health needs of Long COVID patients. At Toivoa, Inc., we are closing this treatment gap with the first FDA-authorized, accessible, highly personalized digital mental health therapeutic – Rauha – which integrates the digital delivery of expert CBT from licensed clinical psychologists with personalized support and guidance mediated via National Health and Wellness Board Certified (NHWBC) certified mental health coaches. Our Rauha platform is currently designed for adults with hearing loss and mobility disabilities, and this project will seek to optimize Rauha to meet the unique accessibility needs of Long COVID patients. The overarching goals of this Phase I SBIR project are to gather peer-review on Rauha from a panel of clinical experts and advisory boards of patients, caregivers, and mental health coaches to reach a consensus opinion on digital therapeutic content for Long COVID patients addressing their mental health needs (Aim 1), customize Rauha to best serve Long COVID patients and their caregivers (Aim 2), and conduct a human factors study with Long COVID patients to evaluate the usability and acceptability of Rauha’s personalized CBT digital therapeutic content with an integrated mental health coach with shared life experiences for addressing their mental health needs (Aim 3). Successful completion of Phase I will position Toivoa for a Phase II program to conduct a powered randomized control clinical trial to evaluate the efficacy of Rauha among Long COVID patients.
