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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

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
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 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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https://hal.archives-ouvertes.fr/hal-03037888
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Submitted on : Thursday, December 3, 2020 - 11:43:57 AM
Last modification on : Tuesday, September 7, 2021 - 3:44:02 PM

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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, Elsevier, 2020, 135, pp.110132. ⟨10.1016/j.jpsychores.2020.110132⟩. ⟨hal-03037888⟩

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