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
2020
Thombs, Brett | 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 | Krishnan, Ankur | Sun, Ying | Levis, Brooke | He, Chen | Turner, Kimberly | Benedetti, Andrea | Culos-Reed, Nicole | El-Baalbaki, Ghassan | Hebblethwaite, Shannon | Bartlett, Susan | Dyas, Laura | Patten, Scott | Fortuné, Catherine | Gietzen, Amy | Guillot, Geneviève | Lewis, Nancy | Nielsen, Karen | Richard, Michelle | Sauvé, Maureen | Welling, Joep | Baron, Murray | Furst, Daniel | Gottesman, Karen | Malcarne, Vanessa | Mayes, Maureen | Mouthon, Luc | Nielson, Warren | Riggs, Robert | Wigley, Fredrick | Assassi, Shervin | Boutron, Isabelle | Ells, Carolyn | van den Ende, Cornelia | Fligelstone, Kim | Frech, Tracy | Godard, Dominique | Harel, Daphna | Hinchcliff, Monique | Hudson, Marie | Johnson, Sindhu | Larche, Maggie | Leite, Catarina | Nguyen, Christelle | Pope, Janet | Portales, Alexandra | Rannou, François | Reyna, Tatiana Sofia Rodriguez | Schouffoer, Anne | Suarez-Almazor, Maria | Agard, Christian | Albert, Alexandra | Andre, Marc | Arsenault, Guylaine | Benzidia, Ilham | Bernstein, Elana | Berthier, Sabine | Bissonnette, Lyne | Boire, Gilles | Bruns, Alessandra | Carreira, Patricia | Casadevall, Marion | Chaigne, Benjamin | Chung, Lorinda | Cohen, Pascal | Correia, Chase | Dagenais, Pierre | Denton, Christopher | Domsic, Robyn | Dubois, Sandrine | Dunne, James | Dunogue, Bertrand | Fare, Regina | Farge-Bancel, Dominique | Fortin, Paul | Gill, Anna | Gordon, Jessica | Granel-Rey, Brigitte | Gyger, Genevieve | Hachulla, Eric | Hatron, Pierre-Yves | Herrick, Ariane | Hij, Adrian | Hoa, Sabrina | Ikic, Alena | Jones, Niall | de B. Fernandes, Artur Jose | Kafaja, Suzanne | Khalidi, Nader | Lambert, Marc | Launay, David | Liang, Patrick | Maillard, Hélène | Maltez, Nancy | Manning, Joanne | Marie, Isabelle | Martin, Maria | Martin, Thierry | Masetto, Ariel | Maurier, François | Mekinian, Arsene | Melchor, Sheila | Nikpour, Mandana | Olagne, Louis | Poindron, Vincent | Proudman, Susanna | Régent, Alexis | Rivière, Sébastien | Robinson, David | Rodriguez, Esther | Roux, Sophie | Smets, Perrine | Smith, Doug | Sobanski, Vincent | Spiera, Robert | Steen, Virginia | Stevens, Wendy | Sutton, Evelyn | Terrier, Benjamin | Thorne, Carter | Varga, John | Wilcox, Pearce | Ayala, Mara Cañedo | Ostbo, Nora | Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
International audience
显示更多 [+] 显示较少 [-]英语. 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.
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