Protocol for a partially nested randomised 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 at-risk scleroderma patients

• Published in: Journal of psychosomatic research Vol. 135; p. 110132
• Main Authors: Thombs, Brett D, Kwakkenbos, Linda, Carrier, Marie-Eve, Bourgeault, Angelica, Tao, Lydia, Harb, Sami, Gagarine, Maria, Rice, Danielle, Bustamante, Laura, Ellis, Kelsey, Duchek, Delaney, Wu, Yin, Bhandari, Parash Mani, Neupane, Dipika, Carboni-Jiménez, Andrea, Henry, Richard S, Krishnan, Ankur, Sun, Ying, Levis, Brooke, He, Chen, Turner, Kimberly A, Benedetti, Andrea, Culos-Reed, Nicole, El-Baalbaki, Ghassan, Hebblethwaite, Shannon, Bartlett, Susan J, Dyas, Laura, Patten, Scott, Varga, John
• Format: Journal Article
• Language: English
• Published: England The Authors. Published by Elsevier Inc 01.08.2020
• Subjects: Anxiety - prevention & control; Coronavirus Infections - epidemiology; Coronavirus Infections - prevention & control; Coronavirus Infections - psychology; COVID-19; Health Promotion - methods; Humans; Pandemics - prevention & control; Patient-Centered Care; Pneumonia, Viral - epidemiology; Pneumonia, Viral - prevention & control; Pneumonia, Viral - psychology; Program Evaluation; Research Design; Risk Assessment; Scleroderma, Systemic - therapy; Social Isolation - psychology; Videoconferencing; COVID-19; RCT; Coronavirus; Trial; Systemic sclerosis; Mental health; Anxiety; Scleroderma
• ISSN: 0022-3999; 1879-1360
• DOI: 10.1016/j.jpsychores.2020.110132

Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.