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 Thombs , Linda Kwakkenbos , Marie-Eve Carrier , Angelica Bourgeault , Lydia Tao , Sami Harb , Maria Gagarine , Danielle Rice , Laura Bustamante , Kelsey Ellis , Delaney Duchek , Yin Wu , Parash Mani Bhandari , Dipika Neupane , Andrea Carboni-Jiménez , Richard Henry , Ankur Krishnan , Ying Sun , Brooke Levis , Chen He , Kimberly Turner , Andrea Benedetti , Nicole Culos-Reed , Ghassan El-Baalbaki , Shannon Hebblethwaite , Susan Bartlett , Laura Dyas , Scott Patten , Catherine Fortuné , Amy Gietzen , Geneviève Guillot , Nancy Lewis , Karen Nielsen , Michelle Richard , Maureen Sauvé , Joep Welling , Murray Baron , Daniel Furst , Karen Gottesman , Vanessa Malcarne , Maureen Mayes , Luc Mouthon , Warren Nielson , Robert Riggs , Fredrick Wigley , Shervin Assassi , Isabelle Boutron , Carolyn Ells , Cornelia van den Ende , Kim Fligelstone , Tracy Frech , Dominique Godard , Daphna Harel , Monique Hinchcliff , Marie Hudson , Sindhu Johnson , Maggie Larche , Catarina Leite , Christelle Nguyen , Janet Pope , Alexandra Portales , François Rannou , Tatiana Sofia Rodriguez Reyna , Anne Schouffoer , Maria Suarez-Almazor , Christian Agard , Alexandra Albert , Marc Andre (1) , Guylaine Arsenault , Ilham Benzidia , Elana Bernstein , Sabine Berthier , Lyne Bissonnette , Gilles Boire , Alessandra Bruns , Patricia Carreira , Marion Casadevall , Benjamin Chaigne , Lorinda Chung , Pascal Cohen , Chase Correia , Pierre Dagenais , Christopher Denton , Robyn Domsic , Sandrine Dubois , James Dunne , Bertrand Dunogue , Regina Fare , Dominique Farge-Bancel , Paul Fortin , Anna Gill , Jessica Gordon , Brigitte Granel-Rey , Genevieve Gyger , Eric Hachulla , Pierre-Yves Hatron , Ariane Herrick , Adrian Hij , Sabrina Hoa , Alena Ikic , Niall Jones , Artur Jose de B. Fernandes , Suzanne Kafaja , Nader Khalidi , Marc Lambert , David Launay , Patrick Liang , Hélène Maillard , Nancy Maltez , Joanne Manning , Isabelle Marie , Maria Martin , Thierry Martin , Ariel Masetto , François Maurier , Arsene Mekinian , Sheila Melchor , Mandana Nikpour , Louis Olagne , Vincent Poindron , Susanna Proudman , Alexis Régent , Sébastien Rivière , David Robinson , Esther Rodriguez , Sophie Roux , Perrine Smets , Doug Smith , Vincent Sobanski , Robert Spiera , Virginia Steen , Wendy Stevens , Evelyn Sutton , Benjamin Terrier , Carter Thorne , John Varga , Pearce Wilcox , Mara Cañedo Ayala , Nora Ostbo

1 M2iSH - Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte

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.

Mots clés: Anxiety; Coronavirus; COVID-19; Mental health; RCT; Scleroderma; Systemic sclerosis; Trial

Domaines: Biologie moléculaire; Bactériologie

Brett Thombs, Linda Kwakkenbos, Marie-Eve Carrier, Angelica Bourgeault, Lydia Tao, et al.. 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. Journal of Psychosomatic Research, 2020, 135, pp.110132. ⟨10.1016/j.jpsychores.2020.110132⟩. ⟨hal-03037888⟩