Serveur d'explorations sur les aspects psychologiques du Covid

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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.

Identifieur interne : 000472 ( Main/Exploration ); précédent : 000471; suivant : 000473

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.

Auteurs : Brett D. Thombs [Canada] ; Linda Kwakkenbos [Pays-Bas] ; Marie-Eve Carrier [Canada] ; Angelica Bourgeault [Canada] ; Lydia Tao [Canada] ; Sami Harb [Canada] ; Maria Gagarine [Canada] ; Danielle Rice [Canada] ; Laura Bustamante [Canada] ; Kelsey Ellis [Canada] ; Delaney Duchek [Canada] ; Yin Wu [Canada] ; Parash Mani Bhandari [Canada] ; Dipika Neupane [Canada] ; Andrea Carboni-Jiménez [Canada] ; Richard S. Henry [Canada] ; Ankur Krishnan [Canada] ; Ying Sun [Canada] ; Brooke Levis [Royaume-Uni] ; Chen He [Canada] ; Kimberly A. Turner [Canada] ; Andrea Benedetti [Canada] ; Nicole Culos-Reed [Canada] ; Ghassan El-Baalbaki [Canada] ; Shannon Hebblethwaite [Canada] ; Susan J. Bartlett [Canada] ; Laura Dyas [États-Unis] ; Scott Patten [Canada] ; John Varga [États-Unis]

Source :

RBID : pubmed:32521358

Descripteurs français

English descriptors

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.


DOI: 10.1016/j.jpsychores.2020.110132
PubMed: 32521358
PubMed Central: PMC7224675


Affiliations:


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<name sortKey="El Baalbaki, Ghassan" sort="El Baalbaki, Ghassan" uniqKey="El Baalbaki G" first="Ghassan" last="El-Baalbaki">Ghassan El-Baalbaki</name>
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<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
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<author>
<name sortKey="Kwakkenbos, Linda" sort="Kwakkenbos, Linda" uniqKey="Kwakkenbos L" first="Linda" last="Kwakkenbos">Linda Kwakkenbos</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.</nlm:affiliation>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea>Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen</wicri:regionArea>
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<settlement type="city">Nimègue</settlement>
<region type="province" nuts="2">Gueldre</region>
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<author>
<name sortKey="Carrier, Marie Eve" sort="Carrier, Marie Eve" uniqKey="Carrier M" first="Marie-Eve" last="Carrier">Marie-Eve Carrier</name>
<affiliation wicri:level="1">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec</wicri:regionArea>
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<author>
<name sortKey="Bourgeault, Angelica" sort="Bourgeault, Angelica" uniqKey="Bourgeault A" first="Angelica" last="Bourgeault">Angelica Bourgeault</name>
<affiliation wicri:level="1">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
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</author>
<author>
<name sortKey="Tao, Lydia" sort="Tao, Lydia" uniqKey="Tao L" first="Lydia" last="Tao">Lydia Tao</name>
<affiliation wicri:level="1">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
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</author>
<author>
<name sortKey="Harb, Sami" sort="Harb, Sami" uniqKey="Harb S" first="Sami" last="Harb">Sami Harb</name>
<affiliation wicri:level="4">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Gagarine, Maria" sort="Gagarine, Maria" uniqKey="Gagarine M" first="Maria" last="Gagarine">Maria Gagarine</name>
<affiliation wicri:level="4">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Rice, Danielle" sort="Rice, Danielle" uniqKey="Rice D" first="Danielle" last="Rice">Danielle Rice</name>
<affiliation wicri:level="4">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Bustamante, Laura" sort="Bustamante, Laura" uniqKey="Bustamante L" first="Laura" last="Bustamante">Laura Bustamante</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Applied Human Sciences, Concordia University, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Ellis, Kelsey" sort="Ellis, Kelsey" uniqKey="Ellis K" first="Kelsey" last="Ellis">Kelsey Ellis</name>
<affiliation wicri:level="4">
<nlm:affiliation>Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Faculty of Kinesiology, University of Calgary, Calgary, Alberta</wicri:regionArea>
<orgName type="university">Université de Calgary</orgName>
<placeName>
<settlement type="city">Calgary</settlement>
<region type="state">Alberta</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Duchek, Delaney" sort="Duchek, Delaney" uniqKey="Duchek D" first="Delaney" last="Duchek">Delaney Duchek</name>
<affiliation wicri:level="4">
<nlm:affiliation>Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Faculty of Kinesiology, University of Calgary, Calgary, Alberta</wicri:regionArea>
<orgName type="university">Université de Calgary</orgName>
<placeName>
<settlement type="city">Calgary</settlement>
<region type="state">Alberta</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Wu, Yin" sort="Wu, Yin" uniqKey="Wu Y" first="Yin" last="Wu">Yin Wu</name>
<affiliation wicri:level="4">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec</wicri:regionArea>
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<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
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</author>
<author>
<name sortKey="Bhandari, Parash Mani" sort="Bhandari, Parash Mani" uniqKey="Bhandari P" first="Parash Mani" last="Bhandari">Parash Mani Bhandari</name>
<affiliation wicri:level="4">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
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</author>
<author>
<name sortKey="Neupane, Dipika" sort="Neupane, Dipika" uniqKey="Neupane D" first="Dipika" last="Neupane">Dipika Neupane</name>
<affiliation wicri:level="4">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Carboni Jimenez, Andrea" sort="Carboni Jimenez, Andrea" uniqKey="Carboni Jimenez A" first="Andrea" last="Carboni-Jiménez">Andrea Carboni-Jiménez</name>
<affiliation wicri:level="4">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec</wicri:regionArea>
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<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
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</author>
<author>
<name sortKey="Henry, Richard S" sort="Henry, Richard S" uniqKey="Henry R" first="Richard S" last="Henry">Richard S. Henry</name>
<affiliation wicri:level="4">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec</wicri:regionArea>
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<placeName>
<settlement type="city">Montréal</settlement>
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</placeName>
</affiliation>
</author>
<author>
<name sortKey="Krishnan, Ankur" sort="Krishnan, Ankur" uniqKey="Krishnan A" first="Ankur" last="Krishnan">Ankur Krishnan</name>
<affiliation wicri:level="1">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
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<author>
<name sortKey="Sun, Ying" sort="Sun, Ying" uniqKey="Sun Y" first="Ying" last="Sun">Ying Sun</name>
<affiliation wicri:level="1">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
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</author>
<author>
<name sortKey="Levis, Brooke" sort="Levis, Brooke" uniqKey="Levis B" first="Brooke" last="Levis">Brooke Levis</name>
<affiliation wicri:level="4">
<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>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</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="He, Chen" sort="He, Chen" uniqKey="He C" first="Chen" last="He">Chen He</name>
<affiliation wicri:level="1">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
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</author>
<author>
<name sortKey="Turner, Kimberly A" sort="Turner, Kimberly A" uniqKey="Turner K" first="Kimberly A" last="Turner">Kimberly A. Turner</name>
<affiliation wicri:level="1">
<nlm:affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Benedetti, Andrea" sort="Benedetti, Andrea" uniqKey="Benedetti A" first="Andrea" last="Benedetti">Andrea Benedetti</name>
<affiliation wicri:level="4">
<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>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</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Culos Reed, Nicole" sort="Culos Reed, Nicole" uniqKey="Culos Reed N" first="Nicole" last="Culos-Reed">Nicole Culos-Reed</name>
<affiliation wicri:level="1">
<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>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</wicri:regionArea>
<wicri:noRegion>Alberta</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="El Baalbaki, Ghassan" sort="El Baalbaki, Ghassan" uniqKey="El Baalbaki G" first="Ghassan" last="El-Baalbaki">Ghassan El-Baalbaki</name>
<affiliation wicri:level="4">
<nlm:affiliation>Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Psychology, Université du Québec à Montréal, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université du Québec à Montréal</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Hebblethwaite, Shannon" sort="Hebblethwaite, Shannon" uniqKey="Hebblethwaite S" first="Shannon" last="Hebblethwaite">Shannon Hebblethwaite</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Applied Human Sciences, Concordia University, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Bartlett, Susan J" sort="Bartlett, Susan J" uniqKey="Bartlett S" first="Susan J" last="Bartlett">Susan J. Bartlett</name>
<affiliation wicri:level="4">
<nlm:affiliation>Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Dyas, Laura" sort="Dyas, Laura" uniqKey="Dyas L" first="Laura" last="Dyas">Laura Dyas</name>
<affiliation wicri:level="2">
<nlm:affiliation>Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Scleroderma Foundation Michigan Chapter, Southfield, MI</wicri:regionArea>
<placeName>
<region type="state">Michigan</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Patten, Scott" sort="Patten, Scott" uniqKey="Patten S" first="Scott" last="Patten">Scott Patten</name>
<affiliation wicri:level="4">
<nlm:affiliation>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.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>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</wicri:regionArea>
<orgName type="university">Université de Calgary</orgName>
<placeName>
<settlement type="city">Calgary</settlement>
<region type="state">Alberta</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Varga, John" sort="Varga, John" uniqKey="Varga J" first="John" last="Varga">John Varga</name>
<affiliation wicri:level="2">
<nlm:affiliation>Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL</wicri:regionArea>
<placeName>
<region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Journal of psychosomatic research</title>
<idno type="eISSN">1879-1360</idno>
<imprint>
<date when="2020" type="published">2020</date>
</imprint>
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<term>Anxiety (prevention & control)</term>
<term>Coronavirus Infections (epidemiology)</term>
<term>Coronavirus Infections (prevention & control)</term>
<term>Coronavirus Infections (psychology)</term>
<term>Health Promotion (methods)</term>
<term>Humans</term>
<term>Pandemics (prevention & control)</term>
<term>Patient-Centered Care</term>
<term>Pneumonia, Viral (epidemiology)</term>
<term>Pneumonia, Viral (prevention & control)</term>
<term>Pneumonia, Viral (psychology)</term>
<term>Program Evaluation</term>
<term>Research Design</term>
<term>Risk Assessment</term>
<term>Scleroderma, Systemic (therapy)</term>
<term>Social Isolation (psychology)</term>
<term>Videoconferencing</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Anxiété (prévention et contrôle)</term>
<term>Communication par vidéoconférence</term>
<term>Humains</term>
<term>Infections à coronavirus (prévention et contrôle)</term>
<term>Infections à coronavirus (psychologie)</term>
<term>Infections à coronavirus (épidémiologie)</term>
<term>Isolement social (psychologie)</term>
<term>Pandémies (prévention et contrôle)</term>
<term>Plan de recherche</term>
<term>Pneumopathie virale (prévention et contrôle)</term>
<term>Pneumopathie virale (psychologie)</term>
<term>Pneumopathie virale (épidémiologie)</term>
<term>Promotion de la santé (méthodes)</term>
<term>Sclérodermie systémique (thérapie)</term>
<term>Soins centrés sur le patient</term>
<term>Évaluation de programme</term>
<term>Évaluation des risques</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Health Promotion</term>
</keywords>
<keywords scheme="MESH" qualifier="méthodes" xml:lang="fr">
<term>Promotion de la santé</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en">
<term>Anxiety</term>
<term>Coronavirus Infections</term>
<term>Pandemics</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr">
<term>Anxiété</term>
<term>Infections à coronavirus</term>
<term>Pandémies</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="psychologie" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Isolement social</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
<term>Social Isolation</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Scleroderma, Systemic</term>
</keywords>
<keywords scheme="MESH" qualifier="thérapie" xml:lang="fr">
<term>Sclérodermie systémique</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Humans</term>
<term>Patient-Centered Care</term>
<term>Program Evaluation</term>
<term>Research Design</term>
<term>Risk Assessment</term>
<term>Videoconferencing</term>
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<keywords scheme="MESH" xml:lang="fr">
<term>Communication par vidéoconférence</term>
<term>Humains</term>
<term>Plan de recherche</term>
<term>Soins centrés sur le patient</term>
<term>Évaluation de programme</term>
<term>Évaluation des risques</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>OBJECTIVE</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>ETHICS AND DISSEMINATION</b>
</p>
<p>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.</p>
</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM">
<PMID Version="1">32521358</PMID>
<DateCompleted>
<Year>2020</Year>
<Month>07</Month>
<Day>17</Day>
</DateCompleted>
<DateRevised>
<Year>2020</Year>
<Month>07</Month>
<Day>17</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1879-1360</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>135</Volume>
<PubDate>
<Year>2020</Year>
<Month>08</Month>
</PubDate>
</JournalIssue>
<Title>Journal of psychosomatic research</Title>
<ISOAbbreviation>J Psychosom Res</ISOAbbreviation>
</Journal>
<ArticleTitle>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.</ArticleTitle>
<Pagination>
<MedlinePgn>110132</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0022-3999(20)30400-1</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jpsychores.2020.110132</ELocationID>
<Abstract>
<AbstractText Label="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.</AbstractText>
<AbstractText Label="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.</AbstractText>
<AbstractText Label="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.</AbstractText>
<CopyrightInformation>Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
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<LastName>Thombs</LastName>
<ForeName>Brett D</ForeName>
<Initials>BD</Initials>
<AffiliationInfo>
<Affiliation>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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kwakkenbos</LastName>
<ForeName>Linda</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Carrier</LastName>
<ForeName>Marie-Eve</ForeName>
<Initials>ME</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Bourgeault</LastName>
<ForeName>Angelica</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Tao</LastName>
<ForeName>Lydia</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Harb</LastName>
<ForeName>Sami</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Gagarine</LastName>
<ForeName>Maria</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Rice</LastName>
<ForeName>Danielle</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bustamante</LastName>
<ForeName>Laura</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ellis</LastName>
<ForeName>Kelsey</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Duchek</LastName>
<ForeName>Delaney</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Wu</LastName>
<ForeName>Yin</ForeName>
<Initials>Y</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bhandari</LastName>
<ForeName>Parash Mani</ForeName>
<Initials>PM</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Neupane</LastName>
<ForeName>Dipika</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Carboni-Jiménez</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Henry</LastName>
<ForeName>Richard S</ForeName>
<Initials>RS</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Krishnan</LastName>
<ForeName>Ankur</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sun</LastName>
<ForeName>Ying</ForeName>
<Initials>Y</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Levis</LastName>
<ForeName>Brooke</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>He</LastName>
<ForeName>Chen</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Turner</LastName>
<ForeName>Kimberly A</ForeName>
<Initials>KA</Initials>
<AffiliationInfo>
<Affiliation>Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Benedetti</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Culos-Reed</LastName>
<ForeName>Nicole</ForeName>
<Initials>N</Initials>
<AffiliationInfo>
<Affiliation>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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>El-Baalbaki</LastName>
<ForeName>Ghassan</ForeName>
<Initials>G</Initials>
<AffiliationInfo>
<Affiliation>Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Hebblethwaite</LastName>
<ForeName>Shannon</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bartlett</LastName>
<ForeName>Susan J</ForeName>
<Initials>SJ</Initials>
<AffiliationInfo>
<Affiliation>Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Dyas</LastName>
<ForeName>Laura</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Patten</LastName>
<ForeName>Scott</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Varga</LastName>
<ForeName>John</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<CollectiveName>Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Patient Advisory Team</CollectiveName>
</Author>
<Author ValidYN="Y">
<CollectiveName>SPIN Investigators</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic">
<Year>2020</Year>
<Month>05</Month>
<Day>14</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>England</Country>
<MedlineTA>J Psychosom Res</MedlineTA>
<NlmUniqueID>0376333</NlmUniqueID>
<ISSNLinking>0022-3999</ISSNLinking>
</MedlineJournalInfo>
<SupplMeshList>
<SupplMeshName Type="Disease" UI="C000657245">COVID-19</SupplMeshName>
</SupplMeshList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D001007" MajorTopicYN="N">Anxiety</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
<QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006293" MajorTopicYN="N">Health Promotion</DescriptorName>
<QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018802" MajorTopicYN="N">Patient-Centered Care</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
<QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015397" MajorTopicYN="N">Program Evaluation</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012107" MajorTopicYN="N">Research Design</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018570" MajorTopicYN="N">Risk Assessment</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012595" MajorTopicYN="N">Scleroderma, Systemic</DescriptorName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012934" MajorTopicYN="N">Social Isolation</DescriptorName>
<QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D049269" MajorTopicYN="N">Videoconferencing</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="Y">Anxiety</Keyword>
<Keyword MajorTopicYN="Y">COVID-19</Keyword>
<Keyword MajorTopicYN="Y">Coronavirus</Keyword>
<Keyword MajorTopicYN="Y">Mental health</Keyword>
<Keyword MajorTopicYN="Y">RCT</Keyword>
<Keyword MajorTopicYN="Y">Scleroderma</Keyword>
<Keyword MajorTopicYN="Y">Systemic sclerosis</Keyword>
<Keyword MajorTopicYN="Y">Trial</Keyword>
</KeywordList>
<CoiStatement>Declaration of Competing Interest All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare that they have no competing interests.</CoiStatement>
<InvestigatorList>
<Investigator ValidYN="Y">
<LastName>Fortuné</LastName>
<ForeName>Catherine</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Gietzen</LastName>
<ForeName>Amy</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Scleroderma Foundation, Danvers, Massachusetts, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Guillot</LastName>
<ForeName>Geneviève</ForeName>
<Initials>G</Initials>
<AffiliationInfo>
<Affiliation>Sclérodermie Québec, Longueuil, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Lewis</LastName>
<ForeName>Nancy</ForeName>
<Initials>N</Initials>
<AffiliationInfo>
<Affiliation>Toronto, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Nielsen</LastName>
<ForeName>Karen</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Scleroderma Society of Ontario, Hamilton, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Richard</LastName>
<ForeName>Michelle</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Past-president of Scleroderma Canada, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Sauvé</LastName>
<ForeName>Maureen</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Scleroderma Society of Ontario and Scleroderma Canada, Hamilton, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Welling</LastName>
<ForeName>Joep</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht, The Netherlands.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Baron</LastName>
<ForeName>Murray</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Furst</LastName>
<ForeName>Daniel E</ForeName>
<Initials>DE</Initials>
<AffiliationInfo>
<Affiliation>Division of Rheumatology, Geffen School of Medicine, University of California, Los Angeles, CA, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Gottesman</LastName>
<ForeName>Karen</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Scleroderma Foundation, Los Angeles, CA, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Malcarne</LastName>
<ForeName>Vanessa</ForeName>
<Initials>V</Initials>
<AffiliationInfo>
<Affiliation>San Diego State University, San Diego, CA, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Mayes</LastName>
<ForeName>Maureen D</ForeName>
<Initials>MD</Initials>
<AffiliationInfo>
<Affiliation>University of Texas McGovern School of Medicine, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Mouthon</LastName>
<ForeName>Luc</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Université Paris Descartes, Paris, France.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Nielson</LastName>
<ForeName>Warren R</ForeName>
<Initials>WR</Initials>
<AffiliationInfo>
<Affiliation>St. Joseph's Health Care, London, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Riggs</LastName>
<ForeName>Robert</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>Scleroderma Foundation, Danvers, MA, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Wigley</LastName>
<ForeName>Fredrick</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Johns Hopkins University School of Medicine, Baltimore, MD, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Assassi</LastName>
<ForeName>Shervin</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>University of Texas McGovern School of Medicine, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Boutron</LastName>
<ForeName>Isabelle</ForeName>
<Initials>I</Initials>
<AffiliationInfo>
<Affiliation>Université Paris Descartes, Hôpitaux de Paris, Paris, France.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Ells</LastName>
<ForeName>Carolyn</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>McGill University, Montreal, Quebec, Canada.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>van den Ende</LastName>
<ForeName>Cornelia</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Sint Maartenskliniek, Nijmegen, The Netherlands.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Fligelstone</LastName>
<ForeName>Kim</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Scleroderma & Raynaud's UK, London, UK.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Frech</LastName>
<ForeName>Tracy</ForeName>
<Initials>T</Initials>
<AffiliationInfo>
<Affiliation>University of Utah, Salt Lake City, UT, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Godard</LastName>
<ForeName>Dominique</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Association des Sclérodermiques de France, Sorel-Moussel, France.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Harel</LastName>
<ForeName>Daphna</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>New York University, New York, NY, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Hinchcliff</LastName>
<ForeName>Monique</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Yale School of Medicine, New Haven, CT, USA.</Affiliation>
</AffiliationInfo>
</Investigator>
<Investigator ValidYN="Y">
<LastName>Hudson</LastName>
<ForeName>Marie</ForeName>
<Initials>M</Initials>
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