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
Brett D. Thombs, Linda Kwakkenbos, Marie-Eve Carrier, Angelica Bourgeault, Lydia Tao, Sami Harb, Maria Gagarine, Danielle B. Rice, Laura Bustamante, Kelsey Ellis, Delaney Duchek, Yin Wu, Parash Mani Bhandari, Dipika Neupane, Andrea Carboni-Jiménez, Richard S. Henry, Ankur Krishnan, Ying Sun, Brooke Levis, Chen He, Kimberly A. Turner, Andrea Benedetti, Nicole Culos-Reed, Ghassan El‐Baalbaki, Shannon Hebblethwaite, Susan J. Bartlett, Laura Dyas, Scott B. Patten, John Varga, Catherine Fortuné, Amy Gietzen, Geneviève Guillot, Nancy Lewis, Karen Nielsen, Michelle Richard, Maureen Sauvé, Joep Welling, Murray Baron, Daniel E. Fürst, Karen Gottesman, Vanessa L. Malcarne, Maureen D. Mayes, Luc Mouthon, Warren R. Nielson, Robert J. Riggs, Fredrick M. Wigley, Shervin Assassi, Isabelle Boutron, Carolyn Ells, C.H.M. van den Ende, Kim Fligelstone, Tracy Frech, Dominique Godard, Daphna Harel, Monique Hinchcliff, Marie Hudson, Sindhu R. Johnson, Maggie Larché, Catarina Leite, Christelle Nguyen, Janet Pope, Alexandra Portales, François Rannou, Tatiana Sofía Rodríguez Reyna, Anne A. Schouffoer, María E. Suarez‐Almazor, C. Agard, Alexandra Albert, Marc André, Guylaine Arsenault, Ilham Benzidia, Elana J. Bernstein, S. Berthier, Lyne Bissonnette, Gilles Boire, Alessandra Bruns, Patrícia Carreira, Marion Casadevall, Benjamin Chaigne, Lorinda Chung, Pascal Cohen, Chase Correia, Pierre Dagenais, Christopher P. Denton, Robyn T. Domsic, Sandrine Dubois, James V. Dunne, Bertrand Dunogué, Regina Faré, Dominique Farge, Paul R. Fortin, Anna Gill, Jessica Gordon, Brigitte Granel-Rey, Geneviève Gyger, É. Hachulla, Pierre‐Yves Hatron, Ariane L. Herrick, A. Hij, Sabrina Hoa
Abstract
OBJECTIVE: 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. METHODS: 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. ETHICS AND DISSEMINATION: 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.