Partially Nested Randomized Controlled Trial to Evaluate the Effectiveness of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program to Reduce Anxiety among Vulnerable Persons with a Pre-existing Medical Condition

People with the autoimmune disease scleroderma are vulnerable in COVID-19 due to frailty, lung involvement, and immunosuppression; they are representative of vulnerable groups in terms of COVID-19 mental health ramifications. No previous randomized controlled trials have tested mental health interventions during infectious disease outbreaks. We leveraged our existing ongoing cohort of over 2,000 people with scleroderma and existing partnerships to launch a new cohort, the Scleroderma Patient-centered Intervention Network (SPIN)-COVID-19 Cohort. We enrolled over 800 people in the cohort to assess mental health during COVID-19. The SPIN-CHAT trial is embedded in the cohort and will test a 4-week (3x/week) videoconference intervention that provides social support and positive mental health education. The primary outcome is anxiety symptoms. Secondary outcomes include symptoms of depression, fear, loneliness, boredom, and social interaction. Our team is uniquely positioned to successfully carry out this research with high-level expertise, an experienced patient advisory team, support of >25 patient organizations internationally, and existing infrastructure. We have successfully enrolled and randomized 172 participants into intervention (N = 86) and waitlist groups (N = 86), and we are delivering the trial intervention. As of May 11, 2020, the SPIN-CHAT Trial is only major COVID-19 mental health trial geared at vulnerable populations in the community. SPIN-CHAT is being tested among people with scleroderma, but could be used with any population of vulnerable individuals who are isolated and experiencing high levels of anxiety in COVID-19, such as people with pre-existing medical conditions or older persons. The study received funding of $100,000 to set up the cohort and deliver the intervention plus $65,000 from Scleroderma Canada, but lacks funding for statistical analyses, follow-up after the immediate end of the intervention period, and knowledge dissemination.