A Partially Nested RCT 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
Phase: NA
Conditions: Scleroderma, Scleroderma, Systemic, Systemic Sclerosis
Sponsor: Lady Davis Institute

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PROTOCOL TITLE: 
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 
 
 
Clinicaltrials.gov ID: NCT04335279 
Document Date: April 1, 2020 
Published: May 14, 2020 
https://doi.org/10.1016/j.jpsychores.2020.110132  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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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 
 
Running Head: Protocol for the SPIN-CHAT Trial 
 
Brett D. Thombs,1-7 Linda Kwakkenbos,8 Marie-Eve Carrier,1 Angelica Bourgeault,1 Lydia 
Tao,1 Sami Harb,1,2 Maria Gagarine,1,3 Danielle Rice,1,5 Laura Bustamante,9 Kelsey Ellis,10 
Delaney Duchek,10 Yin Wu,1,2 Parash Mani Bhandari,1,3 Dipika Neupane,1,3 Andrea Carboni-
Jiménez,1,2 Richard S. Henry,1,2 Ankur Krishnan,1 Ying Sun,1 Brooke Levis,1,3,11 Chen He,1 
Kimberly A Turner,1 Andrea Benedetti,3,4,12 Nicole Culos-Reed,9,13,14 Ghassan El-Baalbaki,15 
Shannon Hebblethwaite,9 Susan J. Bartlett,4,16 Laura Dyas,17 Scott Patten,18,19 John Varga,20 
Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Patient Advisory 
Team,21 SPIN Investigators.22 
 
1Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, 
Canada; 
2Department of Psychiatry, McGill University, Montreal, Quebec, Canada; 
3Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, 
Montreal, Quebec, Canada; 
4Department of Medicine, McGill University, Montreal, Quebec, Canada; 
5Department of Psychology, McGill University, Montreal, Quebec, Canada; 

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6Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, 
Canada; 
7Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada; 
8Department of Clinical Psychology, Behavioural Science Institute, Radboud University, 
Nijmegen, the Netherlands; 
9Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; 
10Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada;  
11Centre for Prognosis Research, School of Primary, Community and Social Care, Keele 
University, Staffordshire, UK; 
12Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, 
Montreal, Quebec, Canada; 
13Department of Oncology, Cumming School of Medicine, Calgary, Canada; 
14Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, 
Calgary, Alberta, Canada; 
15Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada; 
16Research Institute – McGill University Health Centre, Montreal, Quebec, Canada; 
17Scleroderma Foundation Michigan Chapter, Southfield, Michigan, USA; 
18Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; 
19Hotchkiss Brain Institute and O’Brien Institute for Public Health, University of Calgary, Calgary, 
Alberta, Canada; 
20Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, 
Chicago, Illinois, USA; 
21Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Patient Advisory Team 
Members: Catherine Fortuné, Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada; 
Amy Gietzen, Scleroderma Foundation, Danvers, Massachusetts, USA; Geneviève Guillot, 
Sclérodermie Québec, Longueuil, Quebec, Canada; Nancy Lewis, Toronto, Ontario, Canada; 

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Karen Nielsen, Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Michelle Richard, 
Past-president of Scleroderma Canada, Halifax, Nova Scotia, Canada; Maureen Sauvé, 
Scleroderma Society of Ontario and Scleroderma Canada, Hamilton, Ontario, Canada; Joep 
Welling, NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht, The 
Netherlands; 
22SPIN Investigators include: Murray Baron, McGill University, Montreal, Quebec, Canada; 
Daniel E. Furst, Division of Rheumatology, Geffen School of Medicine, University of California, 
Los Angeles, California, USA; Karen Gottesman, Scleroderma Foundation, Los Angeles, 
California, USA; Vanessa Malcarne, San Diego State University, San Diego, California, USA; 
Maureen D. Mayes, University of Texas McGovern School of Medicine, Houston, Texas, USA; 
Luc Mouthon, Université Paris Descartes, Paris, France; Warren R. Nielson, St. Joseph’s Health 
Care, London, Ontario, Canada; Robert Riggs, Scleroderma Foundation, Danvers, 
Massachusetts, USA; Fredrick Wigley, Johns Hopkins University School of Medicine, Baltimore, 
Maryland, USA; Shervin Assassi, University of Texas McGovern School of Medicine, Houston, 
Texas, USA; Isabelle Boutron, Université Paris Descartes, and Assistance Publique - Hôpitaux 
de Paris, Paris, France; Carolyn Ells, McGill University, Montreal, Quebec, Canada; Cornelia 
van den Ende, Sint Maartenskliniek, Nijmegen, The Netherlands; Kim Fligelstone, Scleroderma 
& Raynaud’s UK, London, UK; Tracy Frech, University of Utah, Salt Lake City, Utah, USA; 
Dominique Godard, Association des Sclérodermiques de France, Sorel-Moussel, France; 
Daphna Harel, New York University, New York, New York, USA; Monique Hinchcliff, Yale 
School of Medicine, New Haven, Connecticut, USA; Marie Hudson, McGill University, Montreal, 
Quebec, Canada; Sindhu R. Johnson, Toronto Scleroderma Program, Mount Sinai Hospital, 
Toronto Western Hospital, and University of Toronto, Toronto, Ontario, Canada; Maggie Larche, 
McMaster University, Hamilton, Ontario, Canada; Catarina Leite, University of Minho, Braga, 
Portugal; Christelle Nguyen, Université Paris Descartes, and Assistance Publique - Hôpitaux de 
Paris, Paris, France; Janet Pope, University of Western Ontario, London, Ontario, Canada; 

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Alexandra Portales, Asociación Española de Esclerodermia, Madrid, Spain; François Rannou, 
Université Paris Descartes, and Assistance Publique - Hôpitaux de Paris, Paris, France; Tatiana 
Sofia Rodriguez Reyna, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, 
Mexico City, Mexico; Anne A. Schouffoer, Leiden University Medical Center, Leiden, The 
Netherlands; Maria E. Suarez-Almazor, University of Texas MD Anderson Cancer Center, 
Houston, Texas, USA; Christian Agard, Centre Hospitalier Universitaire - Hôtel-Dieu de Nantes, 
Nantes, France; Alexandra Albert, Université Laval, Quebec, Quebec, Canada; Marc André, 
Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France; Guylaine 
Arsenault, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Ilham Benzidia, Assistance 
Publique - Hôpitaux de Paris, Hôpital St-Louis, Paris, France; Elana J. Bernstein, Columbia 
University, New York, New York, USA; Sabine Berthier, Centre Hospitalier Universitaire Dijon 
Bourgogne, Dijon, France; Lyne Bissonnette, Université de Sherbrooke, Sherbrooke, Quebec, 
Canada; Gilles Boire, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Alessandra 
Bruns, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Patricia Carreira, Servicio de 
Reumatologia del Hospital 12 de Octubre, Madrid, Spain; Marion Casadevall, Assistance 
Publique - Hôpitaux de Paris, Hôpital Cochin, Paris, France; Benjamin Chaigne, Assistance 
Publique - Hôpitaux de Paris, Hôpital Cochin, Paris, France; Lorinda Chung, Stanford 
University, Stanford, California, USA; Pascal Cohen, Assistance Publique - Hôpitaux de Paris, 
Hôpital Cochin, Paris, France; Chase Correia, Northwestern University, Chicago, Illinois, USA; 
Pierre Dagenais, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Christopher Denton, 
Royal Free London Hospital, London, UK; Robyn Domsic, University of Pittsburgh, Pittsburgh, 
Pennsylvania, USA; Sandrine Dubois, Centre Hospitalier Régional Universitaire de Lille, Hôpital 
Claude Huriez, Lille, France; James V. Dunne, St. Paul's Hospital and University of British 
Columbia, Vancouver, British Columbia, Canada; Bertrand Dunogue, Assistance Publique - 
Hôpitaux de Paris, Hôpital Cochin, Paris, France; Regina Fare, Servicio de Reumatologia del 
Hospital 12 de Octubre, Madrid, Spain; Dominique Farge-Bancel, Assistance Publique - 

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Hôpitaux de Paris, Hôpital St-Louis, Paris, France; Paul R. Fortin, CHU de Québec -  Université 
Laval, Quebec, Quebec, Canada; Anna Gill, Royal Free London Hospital, London, UK; Jessica 
Gordon, Hospital for Special Surgery, New York City, New York, USA; Brigitte Granel-Rey, Aix 
Marseille Université, and Assistance Publique - Hôpitaux de Marseille, Hôpital Nord, Marseille, 
France; Genevieve Gyger, Jewish General Hospital and McGill University, Montreal, Quebec, 
Canada; Eric Hachulla, Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude 
Huriez, Lille, France; Pierre-Yves Hatron, Centre Hospitalier Régional Universitaire de Lille, 
Hôpital Claude Huriez, Lille, France; Ariane L Herrick, University of Manchester, Salford Royal 
NHS Foundation Trust, Manchester, UK; Adrian Hij, Assistance Publique - Hôpitaux de Paris, 
Hôpital St-Louis, Paris, France; Sabrina Hoa, Centre hospitalier de l’université de Montréal – 
CHUM, Montreal, Quebec, Canada; Alena Ikic, Université Laval, Quebec, Quebec, Canada; 
Niall Jones, University of Alberta, Edmonton, Alberta, Canada; Artur Jose de B. Fernandes, 
Université de Sherbrooke, Sherbrooke, Quebec, Canada; Suzanne Kafaja, University of 
California, Los Angeles, California, USA; Nader Khalidi, McMaster University, Hamilton, Ontario, 
Canada; Marc Lambert, Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude 
Huriez, Lille, France; David Launay, Centre Hospitalier Régional Universitaire de Lille, Hôpital 
Claude Huriez, Lille, France; Patrick Liang, Université de Sherbrooke, Sherbrooke, Quebec, 
Canada; Hélène Maillard, Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude 
Huriez, Lille, France; Nancy Maltez, University of Ottawa, Ottawa, Ontario, Canada; Joanne 
Manning, Salford Royal NHS Foundation Trust, Salford, UK; Isabelle Marie, CHU Rouen, 
Hôpital de Bois-Guillaume, Rouen, France; Maria Martin, Servicio de Reumatologia del Hospital 
12 de Octubre, Madrid, Spain; Thierry Martin, Les Hôpitaux Universitaires de Strasbourg, 
Nouvel Hôpital Civil, Strasbourg, France; Ariel Masetto, Université de Sherbrooke, Sherbrooke, 
Quebec, Canada; François Maurier, Hôpitaux Privés de Metz, Hôpital Belle-Isle, Metz, France; 
Arsene Mekinian, Assistance Publique - Hôpitaux de Paris, Hôpital St-Antoine, Paris, France; 
Sheila Melchor, Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain; Mandana 

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Nikpour, St Vincent’s Hospital and University of Melbourne, Melbourne, Victoria, Australia; Louis 
Olagne, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France; Vincent 
Poindron, Les Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France; 
Susanna Proudman, Royal Adelaide Hospital and University of Adelaide, Adelaide, South 
Australia, Australia; Alexis Régent, Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, 
Paris, France; Sébastien Rivière, Assistance Publique - Hôpitaux de Paris, Hôpital St-Antoine, 
Paris, France; David Robinson, University of Manitoba, Winnipeg, Manitoba, Canada; Esther 
Rodriguez, Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain; Sophie Roux, 
Université de Sherbrooke, Sherbrooke, Quebec, Canada; Perrine Smets, Centre Hospitalier 
Universitaire Gabriel-Montpied, Clermont-Ferrand, France; Doug Smith, University of Ottawa, 
Ottawa, Ontario, Canada; Vincent Sobanski, Centre Hospitalier Régional Universitaire de Lille, 
Hôpital Claude Huriez, Lille, France; Robert Spiera, Hospital for Special Surgery, New York 
City, New York, USA; Virginia Steen, Georgetown University, Washington, DC, USA; Wendy 
Stevens, St Vincent’s Hospital and University of Melbourne, Melbourne, Victoria, Australia; 
Evelyn Sutton, Dalhousie University, Halifax, Nova Scotia, Canada; Benjamin Terrier, 
Assistance Publique -Hôpitaux de Paris, Hôpital Cochin, Paris, France; Carter Thorne, 
Southlake Regional Health Centre, Newmarket, Ontario, Canada; John Varga, Northwestern 
University, Chicago, Illinois, USA; Pearce Wilcox, St. Paul's Hospital and University of British 
Columbia, Vancouver, British Columbia, Canada; Mara Cañedo Ayala, Jewish General Hospital, 
Montreal, Quebec, Canada; Nora Ostbo, Jewish General Hospital, Montreal, Quebec, Canada. 
 
Word Count: 5,256 
 
Corresponding author:  

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Brett D. Thombs, PhD; 4333 Cote Ste Catherine Road, Montreal, Quebec, Canada H3T 1E4; 
(514) 340-8222 ext. 25112; brett.thombs@mcgill.ca 
 
 

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ABSTRACT 
Objective: Contagious disease outbreaks related restrictions can lead to negative psychological 
outcomes, including loneliness, depression, and anxiety, 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 counseling or 
psychotherapy. We will randomly assign 162 participants to intervention groups of 8 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. 
Funding Source: McGill Interdisciplinary Initiative in Infection and Immunity Emergency 
COVID-19 Research Fund; Scleroderma Society of Ontario; Scleroderma Manitoba; 

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Scleroderma Atlantic. 
Trial Registration: clinicaltrials.gov NCT04335279; registered on April 1, 2020. 
 
Key Words: anxiety; coronavirus; COVID-19; mental health; RCT; scleroderma; systemic 
sclerosis; trial 
 
 

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INTRODUCTION 
Social distancing and movement restrictions during contagious disease outbreaks are 
necessary to reduce spread but can lead to negative social and psychological outcomes, 
including loneliness, depression, and anxiety, particularly in vulnerable populations.1-4 An online 
survey that used snowball sampling techniques and collected data from 1210 respondents from 
194 cities in China in January-February 2020 found that over 50% rated the psychological 
impact of the coronavirus disease 2019 (COVID-19) outbreak as moderate or severe. 
Symptoms of anxiety were rated as the most common psychological problem. Self-reported 
poor physical health status and the presence of a chronic illness were associated with 
symptoms of depression and anxiety.4 
A recent “rapid review” of evidence published in February 2020 identified 24 studies that 
examined the psychological impact of quarantine on participants who had been quarantined 
during outbreaks of severe acute respiratory syndrome (SARS) in China, Hong Kong, and 
Canada in 2003, equine influenza in Australia in 2007, H1N1 influenza in Australia in 2009, 
Ebola in West Africa in 2014, and Middle East Respiratory Syndrome (MERS) in Korea in 2015. 
Pre-quarantine characteristics associated with less favourable psychological status among 
adults under quarantine included history of mental illness, young age, less education, female 
sex, and number of children, although results were not consistent across studies. Factors during 
quarantine associated with worse outcomes included the duration of quarantine, access to 
supplies and information, financial resources, fear of infection and complications, degree of 
social isolation, and boredom.2 No randomised controlled trial (RCT), however, has tested an 
intervention to improve mental health symptoms from quarantine.1-3  
Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease 
characterized by vasculopathy and excessive collagen production.5-7 Onset typically occurs 
between the ages of 30 and 50 years, and approximately 80% of people with SSc are women.7 
SSc can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and 

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heart. Common manifestations include Raynaud’s phenomenon, skin thickening, dyspnea and 
cough, gastroesophageal reflux and other gastrointestinal symptoms.5-7 Disease presentation is 
extremely heterogeneous, and the course of the disease is highly unpredictable.5-7 People with 
SSc commonly experience diminished hand function and mobility limitations, pain, fatigue, sleep 
problems, pruritus, symptoms of depression, and body image distress from disfiguring aspects 
(e.g., skin tightening, pigment changes, hand contractures, telangiectasias).8-13 Many people 
with SSc are at risk of serious complications from COVID-19 if infected due to lung involvement 
(> 40% have interstitial lung disease)14 and common use of immunosuppressant drugs.15 
The Scleroderma Patient-centered Intervention Network (SPIN)16,17 COVID-19 Home-
isolation Activities Together (SPIN-CHAT) Program is a 4-week (3 sessions per week) group 
videoconference-based intervention designed to improve symptoms of anxiety and other mental 
health outcomes among individuals with SSc at risk of poor mental health during the COVID-19 
pandemic. The primary objective of the SPIN-CHAT Trial is to evaluate the effect of the program 
compared to waitlist control on Patient-Reported Outcomes Measurement Information System 
(PROMIS) Anxiety 4a v1.018-20 scores post-intervention among people with SSc with at least 
mild anxiety (baseline T-score  55). Secondary objectives are to evaluate the program’s effects 
post-intervention on symptoms of depression, measured with the Patient Health Questionnaire-
8 (PHQ-8)21; stress, measured with the Perceived Stress Scale (PSS)22; loneliness, measured 
with the 6-item version of the UCLA Loneliness Scale (ULS-6)23; boredom, measured with the 8-
item version of the Multidimensional State Boredom Scale (MSBS-8)24; physical activity, 
measured with the International Physical Activity Questionnaire – modified for the elderly (IPAQ-
E)25; and frequency of social interactions, evaluated with purposely designed items. 
METHODS AND ANALYSIS 
The SPIN-CHAT Trial is a pragmatic, two-arm partially nested RCT (PN-RCT)26,27 that 
will be conducted using the SPIN-COVID-19 Cohort. Pragmatic RCTs are conducted to 
replicate real-world delivery of interventions as much as possible and support decisions on 

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whether interventions should be provided in practice.28-30 The trial will be a PN-RCT because 
participants randomised to the intervention arm will be clustered into intervention groups, and 
members of each intervention group will interact during videoconference sessions; 
participants randomly assigned to the waitlist control will not be clustered and will only 
complete trial measures. The reason that we will use a waitlist control arm and provide the 
program to people in this arm post-trial is that our patient organization partners are invested 
in providing access, and this is important for them to support the trial. It may also increase 
willingness to enrol in the trial by potential participants. 
The trial has been registered (clinicaltrials.gov, NCT04335279), and the protocol follows 
recommendations for reporting from the SPIRIT (Standard Protocol Items: Recommendations 
for Interventional Trials) 2013 Statement.31 Results will be reported in accordance with 
standards described in the Consolidated Standard of Reporting Trials (CONSORT) 
statement32 and CONSORT extensions for nonpharmacologic trials,33 cluster trials,34 
pragmatic trials,28 and the draft extension for RCTs conducted using cohorts and routinely 
collected health data, which is forthcoming.35 Initial participant enrolment and randomisation 
of participants is planned for April 2020. 
SPIN-COVID-19 Cohort Participants 
SPIN is a collaboration of SSc researchers, health care providers, people living with SSc, 
and patient organizations from Canada, the United States, Europe, Mexico and Australia that 
has assembled a large multinational patient cohort to collect longitudinal data on patient-
reported outcomes in SSc and as a framework for embedding RCTs of e-health 
interventions.16,17 To be eligible for the SPIN Cohort, patients must be classified as having SSc 
based on 2013 American College of Rheumatology/European League Against Rheumatism 
criteria,36 confirmed by a SPIN physician; be ≥18 years old; be able to give informed consent; be 
fluent in English, French, or Spanish; and be able to respond to questionnaires via the internet. 
The SPIN Cohort is a convenience sample. Eligible SPIN Cohort patients are recruited at SPIN 

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sites37 during regular medical visits, and written informed consent is obtained. A medical data 
form is submitted online by site personnel to enrol participants. After completion of online 
registration, an automated welcoming email is sent to participants with instructions for activating 
their SPIN account and completing SPIN Cohort measures online. SPIN Cohort participants 
complete online assessments upon enrolment and at 3-month intervals. To date, over 2000 SSc 
patients from 47 centres have been enrolled in SPIN’s web-based cohort (currently 
approximately 1800 active participants).37 Upon enrolment in the SPIN Cohort, all participants 
have consented to be contacted about SPIN sub-studies. 
SPIN Cohort participants who complete measures in English or French will be invited by 
email and by popups during visits to the SPIN Cohort online assessment portal to enrol in the 
SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Additionally, recruitment 
announcements for the SPIN-COVID-19 Cohort will be posted on SPIN’s Facebook page and 
Twitter account and distributed for posting via SPIN’s patient organization partners in countries 
with large English and French-speaking populations, including Canada, the United States, 
France, the United Kingdom, Australia, New Zealand, and the Philippines. Recruitment 
announcements for the SPIN-COVID-19 Cohort will direct potential participants to an online 
Qualtrics web page where they will be provided with information about the SPIN-COVID-19 
Cohort and have the opportunity to consent to participate or decline. SPIN Cohort participants 
who consent to participate will provide their SPIN username (email address linked with their 
SPIN account) to link to SPIN Cohort demographic and medical data. 
Potential participants who are not SPIN Cohort participants will be asked to confirm that 
they are 18 years old, have been classified as having SSc by a physician, and are fluent in 
English or French. Eligible participants will be directed to set up a SPIN-COVID-19 Cohort user 
account and will provide basic demographic and disease-related information. All SPIN-COVID-
19 Cohort participants will be invited to complete measures at baseline and every two weeks for 

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the duration of the COVID-19 pandemic. They will receive email reminders to complete bi-
weekly follow-up assessments. 
Recruitment material for the SPIN-COVID-19 Cohort will state that a lottery will be held as 
an incentive. Three SPIN-COVID-19 participants who complete all scheduled assessments will 
be randomly selected to win a free trip to a SSc patient congress in 2021. This type of incentive 
has been used successfully in previous SPIN sub-studies.38 
SPIN-CHAT Trial Participants 
SPIN-COVID-19 Cohort participants will be eligible for the SPIN-CHAT Trial if they (1) 
have a PROMIS Anxiety 4a v1.018-20 T-score  55; (2) do not report that they have had a 
positive test for the COVID-19 virus; and (3) report that they are not currently receiving mental 
health services, such as counselling or psychotherapy, during the COVID-19 outbreak. Cohort 
participants who were receiving these services at any time prior to the COVID-19 outbreak will 
be eligible for the trial if they are not currently accessing the services. Participants who are 
taking medications for a psychiatric disorder or symptoms will be eligible if they meet all other 
eligibility criteria. Participants will be eligible for enrolment if they meet eligibility criteria at any 
assessment, for the duration of trial enrolment. Consistent with the pragmatic nature of the trial, 
no additional exclusions will be applied. 
Recruitment and Enrolment 
Participants eligible for the SPIN-CHAT Trial will be provided with a brief description of the 
trial in the SPIN-COVID-19 Qualtrics platform immediately after completing their Cohort 
measures and will be asked if they would be interested in participating in the trial. Those who 
express interest will be provided with an online version of the trial consent form, which they can 
also download, and will be given the options of (1) consenting to participate; (2) declining 
participation; or (3) requesting that a member of SPIN’s research team call them to answer 
questions they have about participating in the trial before consenting. Unless participants 
decline participation, they will be asked to provide information on days and times of day when 

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they could take part in videoconference sessions and their language preferences for sessions, 
including (1) only English; (2) only French; (3) either English or French; (4) preferably English, 
but comfortable in French; or (5) preferably French but comfortable in English.  
In addition to describing the study, the consent form will explain (1) that eligible 
participants who enrol will be randomly selected on a rolling basis to be included in the trial 
whenever there are enough participants enrolled to form additional intervention groups on 
particular days and times in English or French; (2) that those randomly selected will be 
randomly assigned to an intervention group or to the waitlist with a 1:1 allocation ratio; (3) that 
participants randomised to the SPIN-CHAT Program plus those allocated to the waitlist will 
complete measures online every two weeks as they would anyway as SPIN-COVID-19 Cohort 
participants; (4) that, depending on the number of participants who enrol with availabilities 
based on language, days, and times, it is possible that some enrolled participants will not be 
randomised; and (5) that, enrolled participants who do not receive the intervention as part of the 
trial, either because they are selected for the waitlist or because they are not selected for the 
program or the waitlist, will be offered the program post-trial if still relevent, pending 
development of the COVID-19 situation. A member of the SPIN research team will call all 
potential participants to confirm eligibility, day and time availability, and desire to participate in 
the trial, prior to completing enrolment.  
Random Selection and Allocation 
SPIN-COVID-19 Cohort participants who provide consent for participation will be entered 
into different pools based on their availabilities and taking into consideration time zone 
differences. Figure 1 illustrates the flow of participants into the trial, and Figure 2 the schedule of 
enrolment, interventions, and assessments. Once there are enough participants to complete an 
intervention group and assign an equal number of participants to waitlist control, a third-party 
randomisation service will randomly select eligible participants and randomly assign selected 

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participants to the intervention group or waitlist control. This process will be repeated until trial 
enrolment is complete. 
SPIN personnel will provide the external service with an anonymised list of participants 
(only ID numbers will be provided) who could participate in an intervention group based on 
language and day and time availabilities. For each intervention group and waitlist control 
pairing, the service will randomly select 16 participants from the pool of enrolled participants 
available based on language, day, and time and will randomly allocate 8 to the intervention 
group and 8 to the waitlist group using block randomisation. One randomisation block will 
include 18 participants (9 intervention, 9 waitlist) to accommodate the total number that we 
anticipate randomising (see section on sample size). 
All participants who are randomised will receive an email to communicate their 
assignment to the SPIN-CHAT Program or waitlist control. A second email will be sent to those 
allocated to the intervention arm with the date and time of their first group session and 
information on how to login to the videoconferencing system and online chatroom.  
Blinding and Protecting Against Sources of Bias 
A potential concern is that participants and the research team members will not be blinded 
to intervention status. In most pragmatic trials of education and psychological interventions, 
including the SPIN-CHAT Trial, participants cannot be blinded. This is understood as part of the 
response to being offered a treatment, similar to what occurs in clinical practice.28,30 A second 
concern relates to the potential for contamination if participants randomised to the SPIN-CHAT 
Program share program material with participants in the waitlist control. To attempt to minimize 
the influence of possible contamination, we will explain this concern to participants in the 
intervention arm of the trial and ask them not to share material or discuss the sessions with 
others outside of their intervention group during the trial. 
Intervention and Comparator 

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Mental health outcomes, including anxiety, among people in quarantine are associated 
with modifiable factors such as degree of isolation, boredom, and ability to manage worry and 
anxiety.2 In addition to psychological strategies, including worry reduction and meditative 
exercises,39,40 exercise has been shown to reduce anxiety.41,42 Among older adults, where 
isolation is a common challenge, activity and social engagement are commonly used to address 
loneliness and feelings of isolation.43,44 Recommendations for the World Health Organization 
and major national public health organizations for managing mental health during the COVID-19 
pandemic emphasize setting and following a routine, managing information sources and 
quantity, staying connected with others, and finding a way to be physically active.45-47 
The SPIN-CHAT Program is a brief group videoconference intervention that was 
developed based on best-practice principles for managing anxiety and worry,39,40 
recommendations for maintaining mental health during COVID-19,45-47 and input from the SPIN 
COVID-19 Patient Advisory Team. The intervention will be delivered 3 times per week for 4 
weeks during the COVID-19 crisis in 60- to 90-minute sessions. Each session will include 3 
segments: (1) engagement via therapeutic recreation activities (20-30 minutes); (2) education 
on information management and anxiety management through psychological and other 
strategies (20-30 minutes); and (3) open discussion and social support (20-30 minutes). Each 
intervention group will be moderated by a member of the research team or by leaders who have 
been trained in our SPIN support group leader training program.48,49 The moderators will support 
participants to develop routines during the COVID-19 crisis and to integrate educational material 
into those routines and will moderate group discussions. Supervision and support of group 
moderators will be provided by a trained social worker with 28 years of total experience and 
over ten years of experience working with the SSc community. Educational segments in each 
session will be delivered by a research team member with experience and training related to the 
topic. 

19 
 
Leisure activities that will be done at the start of each session will include games (e.g., 
Pictionary, charades, pub-style trivia), creative activities (e.g., roll-a-story, where participants roll 
a dice and take turns adding a sentence to a story; home scavenger hunt), cultural activities 
(e.g., virtual museum tours, name that tune), social activities (e.g., share your favourite recipe, 
share travel experiences, bingo with card created with activities the participants have used to 
stay active during the pandemic).  
There will be an initial program overview in the first session. Then, educational segment 
topics will include (1) healthy information management and social connection (session 2); (2) 
managing worry (sessions 3, 7, 11); (3) relaxation strategies (sessions 4 and 8); (4) adapted 
home exercise (sessions 5, 9, 12); and (5) activity engagement at home (sessions 6 and 10). All 
educational segments will be supported by resource materials available to participants via an 
online SPIN-CHAT resource link.  
In the healthy information management and social connection segment, strategies will be 
provided and discussion will be faciliated on how to stay informed via accurate information 
sources while avoiding sensationalist and other non-helpful information.50 Information on using 
simple (e.g., phone) or more advanced technology (e.g., group videoconferencing) to stay 
connected will be discussed, along with strategies for connecting regularly with others. 
The managing worry segments will include an overview of worry, including what it is, the 
difference between helpful and harmful anxiety or worry, how to identify triggers of worry, and 
strategies to manage worry, including identifying different types of worrying, using worry 
journals, worry postponement, and worry time.51,52 Exercises will be done with the group to 
illustrate techniques. In the relaxation segments, an introduction to the purpose of relaxation 
techniques will be presented, and participants will be guided through brief breathing, 
mindfulness, and visualization exercises.53,54 Adaptations for participants with breathing or 
positioning limitations will be made. 

20 
 
The physical activity segments will include an overview of the physical and psychosocial 
benefits of physical activity for maintenance of health for chronic disease management,55-56 
including mental health during the COVID-19 pandemic; movement guidelines to ensure safety; 
and how to monitor daily physical activity. Participants will be guided through movement options 
for the home-based setting, including warm-ups, aerobic, and strength activities. Behaviour 
change techniques to foster building the habit of moving more at home will be taught, including 
goal-setting, scheduling, addressing barriers, and building social support.57-60  
Activity engagement sessions will be guided by the leisure education content model.61 
Sessions will involve interactive group discussion about the benefits of leisure engagement62 for 
persons with SSc, addressing physical, social, emotional, intellectual and spiritual realms of 
health and wellbeing. Sessions will explore barriers to leisure for persons with SSc and include 
tips for finding leisure resources within the participants’ own homes, both in-person and online. 
Based on our previous experience48,49 and consistent with previous trials of 
videoconference training,63,64 8 participants will be assigned to each training group to maximize 
effective interaction and participation. Sessions will be delivered using the GoToMeeting 
videoconferencing platform, a high-performance platform that has been used successfully in 
similar applications65,66 and in feasibility and full-scale trials of SPIN’s support group leader 
training program.48,49 
All group sessions will be video-recorded and audited to ensure adherence to the program 
by two members of the research team. We will use standard methods for evaluating intervention 
fidelity, including observation of entire sessions for a randomly selected sample of 25% of 
sessions. Members of the research team will evaluate adherence to each session’s goals and 
content. Consistent with best-practice recommendations for assessing treatment fidelity,67 this 
will be done using a checklist based on a standardized format adapted for the specific 
components of the SPIN-CHAT Program. 

21 
 
Participants may choose to discontinue their participation in the sessions at any time. We 
do not envision the need to modify the intervention or intervention assignment for any 
participants or to discontinue their participation in the program. However, if acute mental health 
concerns are disclosed to group moderators or other study personnel or if group moderators 
identify reasons to be concerned, these will be discussed immediately with the supervisor of 
group moderators and trial leadership. As appropriate, recommendations will then be made to 
participants to obtain support, and trial participation may be ended. 
Participants assigned to the waitlist will receive notices and reminders to complete trial 
measures as part of the SPIN-COVID-19 Cohort. They will be contacted with information on 
intervention groups post-trial.  
Trial Outcomes 
The primary outcome analysis will compare PROMIS Anxiety 4a v1.0 scores between 
participants randomly assigned to the SPIN-CHAT Program versus the waitlist control at the end 
of the 4-week intervention period. The 4 items of the scale ask participants, in the past 7 days, 
how often: (1) “I felt fearful”; (2) “I found it hard to focus on anything other than my anxiety”; (3) 
“My worries overwhelmed me”; and (4) “I felt uneasy”. Items are scored on a 5-point scale 
(range 1-5), and response options include “never”, “rarely”, “sometimes”, “often”, and “always”. 
Higher scores represent more anxiety. Total raw scores range from 4 to 20 and are obtained by 
summing item scores for each domain. Raw scores are converted into T-scores standardized 
from the general US population (mean=50, standard deviation=10). PROMIS Anxiety 4a v1.0 
has been validated in SSc.68,69 PROMIS Anxiety 4a v1.0 domain scores have been shown to be 
sensitive to change, and minimally important differences have been estimated to be between 
2.3 and 3.4 T-score points.70-73 The 4-item PROMIS Anxiety 4a v1.0 score has been found to be 
highly correlated (r = 0.93) with the 8-item version.70 The scale is available in English and 
French.69 

22 
 
Secondary outcomes include symptoms of depression (PHQ-8),21 stress (PSS),22 
loneliness (ULS-6),23 boredom (MSBS-8),24 physical activity (IPAQ-E),25 and frequency of social 
interactions. 
Depression symptoms (PHQ-8)21: PHQ-8 items measure depressive symptoms over the 
last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day) with higher 
scores (range 0 to 24) indicating more depressive symptoms. The PHQ-8 performs equivalently 
to the PHQ-9,74 which is a valid measure of depressive symptoms in patients with SSc.75 The 
PHQ-8 is available in French and English.76 
Stress (PSS)22: The 10-item PSS measures the degree that respondents appraise their 
lives as stressful; items are designed to reflect the degree that they find their life circumstances 
in the last 4 weeks to be unpredictable, uncontrollable, or overloaded. Items are scored on a 5-
point scale from 0 (never) to 4 (very often). Total scores (range 0 to 40) are computed by 
summing individual items scores, and higher scores reflect greater perceived stress. The PSS 
has been validated in many medical and non-medical populations,77 including in French.78 
Loneliness (ULS-6)23: The 6-item ULS-6 is a short version of the 20-item ULS, which is 
designed to assess subjective feelings of loneliness and social isolation.23 Respondents indicate 
the degree to which feelings described in each item apply to them. Items are scored on a 4-
point scale from 0 (never) to 3 (often); total scores range from 0 to 18. The correlation of the 
ULS-6 with longer versions of the ULS was 0.87 in adolescents and 0.92 among older 
adults.23,79 The ULS-6 items were obtained from a French version of the full ULS.80 
Boredom (MSBS-8)24: The full MSBS81 is a 29-item measure of state boredom with items 
on five factors that load onto a single higher-order factor.24 The 8-item MSBS is a short version 
with scores that correlate very closely to scores from the full MSBS (r = 0.96).82 Item responses 
are on a 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree) and assess the 
degree to which each item reflects the respondant’s experience currently. Total scores range 

23 
 
from 8 to 56 with higher scores reflecting greater boredom. The MSBS-8 was translated into 
French by the SPIN Team using a well-accepted forward-backward translation method.83 
Physical activity (IPAQ-E)25: The 4-item IPAQ-E is a short-form version of the full IPAQ84 
designed to assess physical activity over the last week, including time spent sitting, walking, and 
in moderate and vigorous physical activity.25 Compared to other short-form versions of the 
IPAQ, the IPAQ-E has examples of exercise specific to older adults. The full IPAQ has excellent 
reliability and moderate validity across many different countries,84 and the IPAQ-E has similar 
validity.25 The IPAQ is available in English and French.85 
Frequency of social interactions: Frequency of social interactions with others inside and 
outside of the home will be measured with 4 separate items, including (1) “On a typical day in 
the last week, how many times did you have a social conversation over the phone or a 
videoconferencing platform with one person?” (response = number of times); (2) “On a typical 
day in the last week, how many times did you have a social conversation over a 
videoconferencing platform with multiple people at the same time?” (response = number of 
times; not including SPIN-CHAT sessions); (3) “On a typical day in the last week, how long did 
you spend enjoying conversations with other individuals in the home?” (response = time); (4) 
“On a typical day in the last week, how long did you spend enjoying activities with other 
individuals in the home?” (response = time). Items (3) and (4) will only be displayed to 
participants who live with at least another person in their household. 
Client Satisfaction Questionnaire (CSQ-8)86: An adapted version of the 8-item version of 
the CSQ-8 will be administered to participants assigned to the SPIN-CHAT Program post-
intervention in order to better understand how satisfied participants are with the program.   
Adverse Effects will be assessed by ongoing monitoring during the trial and by asking 
participants post-intervention to describe any adverse experiences or outcomes that may have 
occurred.  
Sample Size 

24 
 
Effects of short anxiety-focused interventions in post-disaster settings are between 0.40 
and 0.80 standardized mean difference (SMD).87,88 This is larger than estimated minimally 
important difference for the PROMIS Anxiety 4a v1.0 score (SMD = 0.23 to 0.34 SMD).70-73 For 
an assumed effect size of SMD = 0.50, a two-tailed test with  = 0.05, and an intra-class 
correlation coefficient (ICC) of 0.05, N=146 provides ≥80% power for our primary outcome, 
PROMIS Anxiety 4a v1.0; assuming 25% dropout, we will recruit 195 participants (98 in 12 
SPIN-CHAT groups; 97 in the waitlist). We believe that this is a conservative power and sample 
size estimate. First, in cluster RCTs, ICC values for individual patient outcomes are typically 
lower than our 0.05 estimate.89-91 If the true ICC is lower than our 0.05 estimate, this will result in 
greater power than estimated. Second, there has been no loss to follow-up in the feasibility trial 
or initial waves of our full-scale trial of the videoconference-based SPIN support group leader 
program,48,49 which has a similar design. Thus, we believe that a 25% loss to follow-up may be 
conservative. 
Data Collection and Management 
Questionnaires for the SPIN-COVID-19 Cohort, including outcome measures for the 
SPIN-CHAT Trial (baseline, 2-week interim, post-intervention), will be completed using the 
online surveying tool Qualtrics. This method has been used in the SPIN support group leader 
training program feasibility and full-scale trials.48,49 Limits on eligible values that can be entered 
will be set to reduce erroneous entries. Data for SPIN Cohort participants will be linked to SPIN 
Cohort demographic and medical data via the email that is used to login to both the SPIN 
Cohort and SPIN-COVID-19 Cohort platforms. To ensure accuracy, we have embedded a check 
into the Qualtrics survey tool to ensure that emails entered by SPIN Cohort participants match 
their SPIN Cohort platform login. Once online survey data is collected, data will be exported to 
the statistics software program STATA. Checking and cleaning of the data will occur within 
SPSS and be done by members of the study team. All information obtained about the 
participants during this study will be treated confidentially within the limits of the law. To protect 

25 
 
the participants’ privacy, upon inclusion in the SPIN-CHAT Trial, a unique participant 
identification number will automatically be assigned to each participant. An encrypted database 
will be created, which will include the participant identification number and name. Data security 
measures in place at Qualtrics are described in the Qualtrics security statement.92 Information 
obtained from the survey and video recordings of the training sessions used to evaluate fidelity 
to program will be kept for 10 years on encrypted hard drives. During the trial, access to the 
data will be limited to the study investigators. Once trial results are reported, de-identified data 
will be made available upon reasonable request. No biological specimens will be collected. 
Data Analysis 
Analyses will be conducted by a statistician blind to trial arm allocation. For the primary 
outcome analysis (PROMIS Anxiety 4a v1.0), we will use an intent-to-treat analysis that 
compares all patients randomly assigned to the SPIN-CHAT Program to all patients assigned to 
the waitlist control. The intervention effect at 4 weeks will be estimated using a linear mixed 
model, adjusted for baseline PROMIS Anxiety 4a v1.0 scores. The model will include a random 
effect to account for clustering of participants in the training groups, but not for participants in 
the waitlist control arm, because there is no clustering in the control arm.26,27 We will investigate 
the effects of missing data using multiple imputation. As a secondary analysis, we will 
additionally adjust for age, sex, baseline loneliness, baseline boredom, and baseline physical 
activity. Analyses of secondary outcomes will similarly be done (1) controlling for baseline 
scores only and (2) controlling for baseline scores, age, sex, and other key baseline measures. 
Statistical significance for all analyses will be determined based on two-sided α = 0.05. In 
addition, we will use complier-average causal effect analysis to estimate effects among patients 
who use the intervention at different levels compared to similar patients in the waitlist arm of the 
trial.93 
Data Monitoring 

26 
 
The trial will be overseen by the SPIN Steering Committee along with the trial 
investigators and the SPIN-COVID-19 Patient Advisory Team. The Steering Committee will 
provide scientific direction for the RCT and will meet periodically to assess its progress. It will be 
responsible for RCT protocol execution, routine monitoring of data quality, recruitment and 
retention, and that the trial is meeting key milestones consistent with the timeline. 
Risks and Potential Benefits of Participating in the SPIN-CHAT Trial 
Participation in the SPIN-CHAT Trial will involve 3 weekly online training sessions for 4 
weeks and completion of online measures. We do not anticipate any safety concerns with 
participation, although if there are any adverse events they will be reported to the local research 
ethics committee. Although it is hypothesized that the SPIN-CHAT Program will improve mental 
health outcomes, particularly symptoms of anxiety, it cannot be guaranteed that participants will 
receive any benefits from this study. However, information learned from this research may lead 
to more effective programs for at-risk individuals due to chronic medical conditions or for other 
vulnerable individuals during infectious disease outbreaks, which could result in benefits to 
others. There will be no financial compensation for participating in the SPIN-CHAT Trial, 
although the lottery provides an incentive for completing SPIN-COVID-19 Cohort measures, as 
described above. 
ETHICS AND DISSEMINATION 
The SPIN-CHAT Trial has been approved by the Research Ethics Committee of Centre 
intégré universitaire de santé et de services sociaux (CIUSSS) du Centre-Ouest-de-l'Île-de-
Montréal (#2021-2286). All participants will provide electronic consent via Qualtrics prior to 
taking part in the study. Any modifications to the protocol which may have an impact on the 
conduct of the study, including changes of study objectives, study design, patient population, 
sample sizes, study procedures, or significant administrative aspects will undergo a formal 
amendment to the protocol. Any such amendment will be submitted to the Research Ethics 
Committee for approval and documented in the trial’s registration. 

27 
 
Our trial team has worked with patient organization partners from around the world and 
with a SPIN-COVID-19 Patient Advisory Team to design the SPIN-CHAT Program and the 
SPIN-CHAT Trial. To the best of our knowledge, no previous trials have evaluated any program 
to improve mental health among individuals who are at risk due to a contagious disease 
outbreak or restrictions to contain the outbreak.1-3 The program, if effective, will be easily 
adapted for other populations. We plan to disseminate results from the trial via peer-reviewed 
publication and national and international conferences. 
TRIAL STATUS 
This is the first version of the protocol, finalized on April 1, 2020. Recruitment began on 
April 7, 2020. 

28 
 
AUTHORS CONTRIBUTIONS 
BDT, LK, MEC, ABourgeault, LT, SH, MG, DR, LB, KE, DD, YW, PMB, DN, ACJ, RSH, 
AK, YS, BL, CH, ABenedetti, NCR, GE-B, SH, SJB, LD, SP, JV, and members of the SPIN 
COVID-19 Patient Advisory Team were responsible for the study conception and design, 
including development and review of program curriculum and materials. BDT drafted the 
manuscript. All authors provided a critical review and approved the final manuscript. BDT is the 
guarantor. 
 
COMPETING INTERESTS STATEMENT 
All authors have completed the ICMJE uniform disclosure form at 
www.icmje.org/coi_disclosure.pdf and declare that they have no competing interests. 
 
FUNDING STATEMENT 
The SPIN-CHAT Trial was funded by the McGill Interdisciplinary Initiative in Infection and 
Immunity Emergency COVID-19 Research Fund, the Scleroderma Society of Ontario, 
Scleroderma Manitoba, and Scleroderma Atlantic. Drs. Wu and Levis were supported by Fonds 
de recherche du Québec – Santé Postdoctoral Training Fellowships, Mr. Harb and Ms. Carboni-
Jiménez were supported by Canadian Institutes of Health Research (CIHR) Canadian Graduate 
Scholarships, Ms. Rice was supported by a CIHR Vanier Graduate Scholarship, Ms. Ellis was 
supported by an Alberta Innovates Strategies for Patient-oriented Research graduate 
studentship, Ms. Ducheck was supported by a University of Calgary Alberta Graduate Excellence 
Scholarship, Mr. Bhandari was supported by a Research Institute of the McGill University Health 
Centre studentship, and Ms. Neupane was supported by a G.R. Caverhill Fellowship from the 
Faculty of Medicine, McGill University, all unrelated to the present study. No sponsor or funder 
was involved in the study design; in the collection, analysis and interpretation of the data; in the 
writing of the report; or in the decision to submit the paper for publication. 

29 
 
 
 

30 
 
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40 
 
Figure 1. SPIN Cohort, SPIN-COVID-19 Cohort, and SPIN-CHAT Trial Flow Diagram  
 
 
 
 
 
 
 
Patients enrolled by SPIN sites 
in SPIN Cohort 
Active in SPIN Cohort 
Randomly assigned to 
SPIN-CHAT 
intervention 
Not Active: 
• Not yet activated by patient 
• Withdrawn without activation 
• Activated then withdrawn 
Ineligible for SPIN-CHAT: 
• T-score <55 on PROMIS 
Anxiety 4a v1.0 
• Engaged in work from home 
on a typical day 
• Receiving counseling or 
therapy currently 
Offered enrolment in SPIN-
CHAT 
Enrolled in SPIN-COVID-19 
Cohort and assessed for trial 
eligibility during routine 
assessment 
Not in SPIN-COVID-19 Cohort 
• SPIN Cohort assessments not 
in English or French 
• Did not enrol in SPIN-COVID-
19 Cohort 
4-week post-intervention 
period follow-up via SPIN-
COVID-19 Cohort 
No Enrolment: 
• Declined offer of enrolment 
Random selection to SPIN-
CHAT if matched group 
language, day, time 
No random selection: 
• No matching group by 
language, day, time 
• Not randomly selected despite 
match 
Randomly assigned to 
waitlist control 
4-week post-intervention 
period follow-up via SPIN-
COVID-19 Cohort 

41 
 
FIGURE 2. Schedule of enrolment, interventions and assessments 
 
 
Enrolment 
Allocation 
Post-allocation 
Post-Trial 
TIMEPOINT 
Pre-
intervention 
0 
2 weeks 
interim 
measures 
Post-
intervention 
(4 weeks) 
After all 
intervention 
group 
complete 
Enrolment: 
Eligibility screen 
X 
 
 
 
 
Informed consent 
X 
 
 
 
 
Participant 
availabilities 
X 
 
 
 
 
Selection and 
Allocation 
 
X 
 
 
 
SPIN-CHAT Program (Intervention): 
Intervention group 
 
 
X 
X 
 
Waitlist control group 
 
 
 
 
X 
Trial Assessments: 
Demographics 
X 
 
 
 
 
Anxiety symptoms 
(PROMIS Anxiety 4a 
v1.0) 
X 
 
X 
X 
 
Depressive symptoms 
(PHQ-8) 
X 
 
X 
X 
 
Stress (PSS) 
X 
 
X 
X 
 
Loneliness (ULS-6) 
X 
 
X 
X 
 
Boredom (MSBS-8) 
X 
 
X 
X 
 
Physical Activity 
(IPAQ-E) 
X 
 
X 
X 
 
Social Contacts 
X 
 
X 
X