A Partially Nested RCT to Evaluate the Effectiveness of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program to Reduce Anxiety Among At-Risk Scleroderma Patients

Background: Social distancing and movement restrictions during contagious disease outbreaks are necessary to reduce spread but can lead to negative social and psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations. An online survey that used snowball sampling techniques and collected data from 1210 respondents from 194 cities in China in January-February 2020 found that over 50% rated the psychological impact of the coronavirus disease 2019 (COVID-19) outbreak as moderate or severe. Symptoms of anxiety were rated as the most common psychological problem. Self-reported poor physical health status and the presence of a chronic illness were associated with symptoms of depression and anxiety.

Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Onset typically occurs between the ages of 30 and 50 years, and approximately 80% of people with SSc are women. SSc can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Disease presentation is extremely heterogeneous, and the course of the disease is highly unpredictable. People with SSc commonly experience hand function and mobility limitations, pain, fatigue, sleep problems, pruritus, symptoms of depression, and body image distress from disfiguring aspects (e.g., skin tightening, pigment changes, hand contractures, telangiectasias). Many people with SSc are at risk of serious complications from COVID-19 if infected due to lung involvement (> 40% have interstitial lung disease) and common use of immunosuppressant drugs.

The Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program is a group videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with SSc at risk of poor mental health during the COVID-19 pandemic. The primary objective of the SPIN-CHAT Trial is to evaluate the effect of the program compared to waitlist control on patient reported symptoms of anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0 scores.

Recruitment and Enrolment: SPIN is a collaboration of SSc researchers, health care providers, people living with SSc, and patient organizations from Canada, the United States, Europe, Mexico and Australia that has assembled a large multinational patient cohort to collect longitudinal data on patient-reported outcomes in SSc and as a framework for embedding RCTs of e-health interventions. SPIN Cohort participants complete online assessments upon enrolment and at 3-month intervals. To date, over 2000 SSc patients from 47 centres have been enrolled in SPIN's web-based cohort (currently approximately 1800 active participants).

SPIN Cohort participants will be invited by email and by popups to enrol in the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Additionally, recruitment announcements for the SPIN-COVID-19 Cohort will be posted on SPIN's social media and distributed through our patient organization partners. All SPIN-COVID-19 Cohort participants will be invited to complete measures at baseline and every two weeks for the duration of the COVID-19 pandemic. They will receive email reminders to complete bi-weekly follow-up assessments.