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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.

J Psychosom Res. 2020 May 14;:110132

Authors: Fortuné C, Gietzen A, Guillot G, Lewis N, Nielsen K, Richard M, Sauvé M, Welling J, SPIN Investigators, Baron M, Furst DE, Gottesman K, Malcarne V, Mayes MD, Mouthon L, Nielson WR, Riggs R, Wigley F, Assassi S, Boutron I, Ells C, van den Ende C, Fligelstone K, Frech T, Godard D, Harel D, Hinchcliff M, Hudson M, Johnson SR, Larche M, Leite C, Nguyen C, Pope J, Portales A, Rannou F, Reyna TSR, Schouffoer AA, Suarez-Almazor ME, Agard C, Albert A, André M, Arsenault G, Benzidia I, Bernstein EJ, Berthier S, Bissonnette L, Boire G, Bruns A, Carreira P, Casadevall M, Chaigne B, Chung L, Cohen P, Correia C, Dagenais P, Denton C, Domsic R, Dubois S, Dunne JV, Dunogue B, Fare R, Farge-Bancel D, Fortin PR, Gill A, Gordon J, Granel-Rey B, Gyger G, Hachulla E, Hatron PY, Herrick AL, Hij A, Hoa S, Ikic A, Jones N, Fernandes AJB, Kafaja S, Khalidi N, Lambert M, Launay D, Liang P, Maillard H, Maltez N, Manning J, Marie I, Martin M, Martin T, Masetto A, Maurier F, Mekinian A, Melchor S, Nikpour M, Olagne L, Poindron V, Proudman S, Régent A, Rivière S, Robinson D, Rodriguez E, Roux S, Smets P, Smith D, Sobanski V, Spiera R, Steen V, Stevens W, Sutton E, Terrier B, Thorne C, Varga J, Wilcox P, Ayala MC, Ostbo N, Thombs BD, Kwakkenbos L, Carrier ME, Bourgeault A, Tao L, Harb S, Gagarine M, Rice D, Bustamante L, Ellis K, Duchek D, Wu Y, Bhandari PM, Neupane D, Carboni-Jiménez A, Henry RS, Krishnan A, Sun Y, Levis B, He C, Turner KA, Benedetti A, Culos-Reed N, El-Baalbaki G, Hebblethwaite S, Bartlett SJ, Dyas L, Patten S, Varga J, Scleroderma Patient-centered Intervention Network (SPIN), COVID-19 Patient Advisory Team

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