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 D 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 S Henry; Ankur Krishnan; Ying Sun; Brooke Levis; Chen He; Kimberly A Turner; Andrea Benedetti; Nicole Culos-Reed; Ghassan El-Baalbaki; Shannon Hebblethwaite; Susan J Bartlett; Laura Dyas; Scott Patten; John Varga; Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Patient Advisory Team; SPIN Investigators

doi:10.1016/j.jpsychores.2020.110132

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 Aug:135:110132. doi: 10.1016/j.jpsychores.2020.110132. Epub 2020 May 14.

Authors

Brett D Thombs¹, Linda Kwakkenbos², Marie-Eve Carrier³, Angelica Bourgeault³, Lydia Tao³, Sami Harb⁴, Maria Gagarine⁵, Danielle Rice⁶, Laura Bustamante⁷, Kelsey Ellis⁸, Delaney Duchek⁸, Yin Wu⁴, Parash Mani Bhandari⁵, Dipika Neupane⁵, Andrea Carboni-Jiménez⁴, Richard S Henry⁴, Ankur Krishnan³, Ying Sun³, Brooke Levis⁹, Chen He³, Kimberly A Turner³, Andrea Benedetti¹⁰, Nicole Culos-Reed¹¹, Ghassan El-Baalbaki¹², Shannon Hebblethwaite⁷, Susan J Bartlett¹³, Laura Dyas¹⁴, Scott Patten¹⁵, John Varga¹⁶; Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Patient Advisory Team; SPIN Investigators

Collaborators

Catherine Fortuné¹⁷, Amy Gietzen¹⁸, Geneviève Guillot¹⁹, Nancy Lewis²⁰, Karen Nielsen²¹, Michelle Richard²², Maureen Sauvé²³, Joep Welling²⁴, Murray Baron²⁵, Daniel E Furst²⁶, Karen Gottesman²⁷, Vanessa Malcarne²⁸, Maureen D Mayes²⁹, Luc Mouthon³⁰, Warren R Nielson³¹, Robert Riggs³², Fredrick Wigley³³, Shervin Assassi²⁹, Isabelle Boutron³⁴, Carolyn Ells²⁵, Cornelia van den Ende³⁵, Kim Fligelstone³⁶, Tracy Frech³⁷, Dominique Godard³⁸, Daphna Harel³⁹, Monique Hinchcliff⁴⁰, Marie Hudson²⁵, Sindhu R Johnson⁴¹, Maggie Larche⁴², Catarina Leite⁴³, Christelle Nguyen³⁴, Janet Pope⁴⁴, Alexandra Portales⁴⁵, François Rannou³⁴, Tatiana Sofia Rodriguez Reyna⁴⁶, Anne A Schouffoer⁴⁷, Maria E Suarez-Almazor⁴⁸, Christian Agard⁴⁹, Alexandra Albert⁵⁰, Marc André⁵¹, Guylaine Arsenault⁵², Ilham Benzidia⁵³, Elana J Bernstein⁵⁴, Sabine Berthier⁵⁵, Lyne Bissonnette⁵², Gilles Boire⁵², Alessandra Bruns⁵², Patricia Carreira⁵⁶, Marion Casadevall⁵⁷, Benjamin Chaigne⁵⁷, Lorinda Chung⁵⁸, Pascal Cohen⁵⁷, Chase Correia⁵⁹, Pierre Dagenais⁵², Christopher Denton⁶⁰, Robyn Domsic⁶¹, Sandrine Dubois⁶², James V Dunne⁶³, Bertrand Dunogue⁵⁷, Regina Fare⁵⁶, Dominique Farge-Bancel⁵³, Paul R Fortin⁶⁴, Anna Gill⁶⁰, Jessica Gordon⁶⁵, Brigitte Granel-Rey⁶⁶, Genevieve Gyger⁶⁷, Eric Hachulla⁶², Pierre-Yves Hatron⁶², Ariane L Herrick⁶⁸, Adrian Hij⁵³, Sabrina Hoa⁶⁹, Alena Ikic⁵⁰, Niall Jones⁷⁰, Artur Jose de B Fernandes⁵², Suzanne Kafaja⁷¹, Nader Khalidi⁴², Marc Lambert⁶², David Launay⁶², Patrick Liang⁵², Hélène Maillard⁶², Nancy Maltez⁷², Joanne Manning⁷³, Isabelle Marie⁷⁴, Maria Martin⁵⁶, Thierry Martin⁷⁵, Ariel Masetto⁵², François Maurier⁷⁶, Arsene Mekinian⁷⁷, Sheila Melchor⁵⁶, Mandana Nikpour⁷⁸, Louis Olagne⁵¹, Vincent Poindron⁷⁵, Susanna Proudman⁷⁹, Alexis Régent⁵⁷, Sébastien Rivière⁷⁷, David Robinson⁸⁰, Esther Rodriguez⁵⁶, Sophie Roux⁵², Perrine Smets⁵¹, Doug Smith⁷², Vincent Sobanski⁶², Robert Spiera⁶⁵, Virginia Steen⁸¹, Wendy Stevens⁷⁸, Evelyn Sutton⁸², Benjamin Terrier⁵⁷, Carter Thorne⁸³, John Varga⁵⁹, Pearce Wilcox⁸⁴, Mara Cañedo Ayala⁸⁵, Nora Ostbo⁸⁵

Affiliations

¹ Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.
² Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.
³ Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.
⁴ Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.
⁵ Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
⁶ Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.
⁷ Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.
⁸ Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
⁹ Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.
¹⁰ Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.
¹¹ Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.
¹² Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.
¹³ Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.
¹⁴ Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.
¹⁵ Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.
¹⁶ Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
¹⁷ Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada.
¹⁸ Scleroderma Foundation, Danvers, Massachusetts, USA.
¹⁹ Sclérodermie Québec, Longueuil, Quebec, Canada.
²⁰ Toronto, Ontario, Canada.
²¹ Scleroderma Society of Ontario, Hamilton, Ontario, Canada.
²² Past-president of Scleroderma Canada, Halifax, Nova Scotia, Canada.
²³ Scleroderma Society of Ontario and Scleroderma Canada, Hamilton, Ontario, Canada.
²⁴ NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht, The Netherlands.
²⁵ McGill University, Montreal, Quebec, Canada.
²⁶ Division of Rheumatology, Geffen School of Medicine, University of California, Los Angeles, CA, USA.
²⁷ Scleroderma Foundation, Los Angeles, CA, USA.
²⁸ San Diego State University, San Diego, CA, USA.
²⁹ University of Texas McGovern School of Medicine, Houston, TX, USA.
³⁰ Université Paris Descartes, Paris, France.
³¹ St. Joseph's Health Care, London, Ontario, Canada.
³² Scleroderma Foundation, Danvers, MA, USA.
³³ Johns Hopkins University School of Medicine, Baltimore, MD, USA.
³⁴ Université Paris Descartes, Hôpitaux de Paris, Paris, France.
³⁵ Sint Maartenskliniek, Nijmegen, The Netherlands.
³⁶ Scleroderma & Raynaud's UK, London, UK.
³⁷ University of Utah, Salt Lake City, UT, USA.
³⁸ Association des Sclérodermiques de France, Sorel-Moussel, France.
³⁹ New York University, New York, NY, USA.
⁴⁰ Yale School of Medicine, New Haven, CT, USA.
⁴¹ Toronto Scleroderma Program, Mount Sinai Hospital, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.
⁴² McMaster University, Hamilton, Ontario, Canada.
⁴³ University of Minho, Braga, Portugal.
⁴⁴ University of Western Ontario, London, Ontario, Canada.
⁴⁵ Asociación Española de Esclerodermia, Madrid, Spain.
⁴⁶ Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
⁴⁷ Leiden University Medical Center, Leiden, The Netherlands.
⁴⁸ University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁴⁹ Centre Hospitalier Universitaire, Hôtel-Dieu de Nantes, Nantes, France.
⁵⁰ Université Laval, Quebec, Quebec, Canada.
⁵¹ Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.
⁵² Université de Sherbrooke, Sherbrooke, Quebec, Canada.
⁵³ Hôpitaux de Paris, Hôpital St-Louis, Paris, France.
⁵⁴ Columbia University, New York, NY, USA.
⁵⁵ Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France.
⁵⁶ Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain.
⁵⁷ Hôpitaux de Paris, Hôpital Cochin, Paris, France.
⁵⁸ Stanford University, Stanford, CA, USA.
⁵⁹ Northwestern University, Chicago, IL, USA.
⁶⁰ Royal Free London Hospital, London, UK.
⁶¹ University of Pittsburgh, Pittsburgh, PA, USA.
⁶² Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.
⁶³ St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
⁶⁴ CHU de Québec, Université Laval, Quebec, Quebec, Canada.
⁶⁵ Hospital for Special Surgery, New York City, NY, USA.
⁶⁶ Aix Marseille Université, Hôpitaux de Marseille, Hôpital Nord, Marseille, France.
⁶⁷ Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
⁶⁸ University of Manchester, Salford Royal NHS Foundation Trust, Manchester, UK.
⁶⁹ Centre hospitalier de l'université de Montréal - CHUM, Montreal, Quebec, Canada.
⁷⁰ University of Alberta, Edmonton, Alberta, Canada.
⁷¹ University of California, Los Angeles, CA, USA.
⁷² University of Ottawa, Ottawa, Ontario, Canada.
⁷³ Salford Royal NHS Foundation Trust, Salford, UK.
⁷⁴ CHU Rouen, Hôpital de Bois-Guillaume, Rouen, France.
⁷⁵ Les Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France.
⁷⁶ Hôpitaux Privés de Metz, Hôpital Belle-Isle, Metz, France.
⁷⁷ Hôpitaux de Paris, Hôpital St-Antoine, Paris, France.
⁷⁸ St Vincent's Hospital, University of Melbourne, Melbourne, Victoria, Australia.
⁷⁹ Royal Adelaide Hospital, University of Adelaide, Adelaide, South Australia, Australia.
⁸⁰ University of Manitoba, Winnipeg, Manitoba, Canada.
⁸¹ Georgetown University, Washington, DC, USA.
⁸² Dalhousie University, Halifax, Nova Scotia, Canada.
⁸³ Southlake Regional Health Centre, Newmarket, Ontario, Canada.
⁸⁴ St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada.
⁸⁵ Jewish General Hospital, Montreal, Quebec, Canada.

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 outcomes among at-risk individuals during contagious disease outbreak.

Keywords: Anxiety; COVID-19; Coronavirus; Mental health; RCT; Scleroderma; Systemic sclerosis; Trial.

Publication types

Randomized Controlled Trial

MeSH terms

Anxiety / prevention & control*
COVID-19
Coronavirus Infections / epidemiology
Coronavirus Infections / prevention & control
Coronavirus Infections / psychology*
Health Promotion / methods*
Humans
Pandemics / prevention & control
Patient-Centered Care
Pneumonia, Viral / epidemiology
Pneumonia, Viral / prevention & control
Pneumonia, Viral / psychology*
Program Evaluation
Research Design
Risk Assessment
Scleroderma, Systemic / therapy*
Social Isolation / psychology
Videoconferencing

Grants and funding

KL2 TR003168/TR/NCATS NIH HHS/United States