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

Thombs, B.D.; Kwakkenbos, L.; Carrier, M.E.; Bourgeault, A.; Tao, L.D.; Harb, S.; ... ; SPIN Investigators (2020)

Article / Letter to editor

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 video-conference. 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.

• Anxiety
• Coronavirus
• COVID-19
• Mental health
• RCT
• Scleroderma
• Systemic sclerosis
• Trial

• All authors: Thombs, B.D.; Kwakkenbos, L.; Carrier, M.E.; Bourgeault, A.; Tao, L.D.; Harb, S.; Gagarine, M.; Rice, D.; Bustamante, L.; Ellis, K.; Duchek, D.; Wu, Y.; Bhandari, P.M.; Neupane, D.; Carboni-Jimenez, A.; Henry, R.S.; Krishnan, A.; Sun, Y.; Levis, B.; He, C.; Turner, K.A.; Benedetti, A.; Culos-Reed, N.; El-Baalbaki, G.; Hebblethwaite, S.; Bartlett, S.J.; Dyas, L.; Patten, S.; Varga, J.; Fortune, C.; Gietzen, A.; Guillot, G.; Lewis, N.; Nielsen, K.; Richard, M.; Sauve, M.; Welling, J.; Baron, M.; Furst, D.E.; Gottesman, K.; Malcarne, V.; Mayes, M.D.; Mouthon, L.; Nielson, W.R.; Riggs, R.; Wigley, F.; Assassi, S.; Boutron, I.; Ells, C.; Ende, C. van den; Fligelstone, K.; Frech, T.; Godard, D.; Harel, D.; Hinchcliff, M.; Hudson, M.; Johnson, S.R.; Larche, M.; Leite, C.; Nguyen, C.; Pope, J.; Portales, A.; Rannou, F.; Reyna, T.S.R.; Schouffoer, A.A.; Suarez-Almazor, M.E.; Agard, C.; Albert, A.; Andre, M.; Arsenault, G.; Benzidia, I.; Bernstein, E.J.; 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, J.V.; Dunogue, B.; Fare, R.; Farge-Bancel, D.; Fortin, P.R.; Gill, A.; Gordon, J.; Granel-Rey, B.; Gyger, G.; Hachulla, E.; Hatron, P.Y.; Herrick, A.L.; Hij, A.; Hoa, S.; Ikic, A.; Jones, N.; Fernandes, A.J.D.; 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.; Regent, A.; Riviere, 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.; Wilcox, P.; Ayala, M.C.; Ostbo, N.; Scleroderma Patient-ctr Interventi; SPIN Investigators
• Date: 2020-08-01
• Journal: Journal of Psychosomatic Research
• Volume: 135
• DOI: doi:10.1016/j.jpsychores.2020.110132
• Link: https://www.sciencedirect.com/science/article/pii/S0022399920304001?via%...