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.
Anxiety
/ prevention & control
COVID-19
Coronavirus Infections
/ epidemiology
Health Promotion
/ methods
Humans
Pandemics
/ prevention & control
Patient-Centered Care
Pneumonia, Viral
/ epidemiology
Program Evaluation
Research Design
Risk Assessment
Scleroderma, Systemic
/ therapy
Social Isolation
/ psychology
Videoconferencing
Anxiety
COVID-19
Coronavirus
Mental health
RCT
Scleroderma
Systemic sclerosis
Trial
Journal
Journal of psychosomatic research
ISSN: 1879-1360
Titre abrégé: J Psychosom Res
Pays: England
ID NLM: 0376333
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
04
04
2020
revised:
03
05
2020
accepted:
04
05
2020
pubmed:
11
6
2020
medline:
18
7
2020
entrez:
11
6
2020
Statut:
ppublish
Résumé
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. 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. 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.
Identifiants
pubmed: 32521358
pii: S0022-3999(20)30400-1
doi: 10.1016/j.jpsychores.2020.110132
pmc: PMC7224675
pii:
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
110132Subventions
Organisme : NCATS NIH HHS
ID : KL2 TR003168
Pays : United States
Investigateurs
Catherine Fortuné
(C)
Amy Gietzen
(A)
Geneviève Guillot
(G)
Nancy Lewis
(N)
Karen Nielsen
(K)
Michelle Richard
(M)
Maureen Sauvé
(M)
Joep Welling
(J)
Murray Baron
(M)
Daniel E Furst
(DE)
Karen Gottesman
(K)
Vanessa Malcarne
(V)
Maureen D Mayes
(MD)
Luc Mouthon
(L)
Warren R Nielson
(WR)
Robert Riggs
(R)
Fredrick Wigley
(F)
Shervin Assassi
(S)
Isabelle Boutron
(I)
Carolyn Ells
(C)
Cornelia van den Ende
(C)
Kim Fligelstone
(K)
Tracy Frech
(T)
Dominique Godard
(D)
Daphna Harel
(D)
Monique Hinchcliff
(M)
Marie Hudson
(M)
Sindhu R Johnson
(SR)
Maggie Larche
(M)
Catarina Leite
(C)
Christelle Nguyen
(C)
Janet Pope
(J)
Alexandra Portales
(A)
François Rannou
(F)
Tatiana Sofia Rodriguez Reyna
(TSR)
Anne A Schouffoer
(AA)
Maria E Suarez-Almazor
(ME)
Christian Agard
(C)
Alexandra Albert
(A)
Marc André
(M)
Guylaine Arsenault
(G)
Ilham Benzidia
(I)
Elana J Bernstein
(EJ)
Sabine Berthier
(S)
Lyne Bissonnette
(L)
Gilles Boire
(G)
Alessandra Bruns
(A)
Patricia Carreira
(P)
Marion Casadevall
(M)
Benjamin Chaigne
(B)
Lorinda Chung
(L)
Pascal Cohen
(P)
Chase Correia
(C)
Pierre Dagenais
(P)
Christopher Denton
(C)
Robyn Domsic
(R)
Sandrine Dubois
(S)
James V Dunne
(JV)
Bertrand Dunogue
(B)
Regina Fare
(R)
Dominique Farge-Bancel
(D)
Paul R Fortin
(PR)
Anna Gill
(A)
Jessica Gordon
(J)
Brigitte Granel-Rey
(B)
Genevieve Gyger
(G)
Eric Hachulla
(E)
Pierre-Yves Hatron
(PY)
Ariane L Herrick
(AL)
Adrian Hij
(A)
Sabrina Hoa
(S)
Alena Ikic
(A)
Niall Jones
(N)
Artur Jose de B Fernandes
(AJ)
Suzanne Kafaja
(S)
Nader Khalidi
(N)
Marc Lambert
(M)
David Launay
(D)
Patrick Liang
(P)
Hélène Maillard
(H)
Nancy Maltez
(N)
Joanne Manning
(J)
Isabelle Marie
(I)
Maria Martin
(M)
Thierry Martin
(T)
Ariel Masetto
(A)
François Maurier
(F)
Arsene Mekinian
(A)
Sheila Melchor
(S)
Mandana Nikpour
(M)
Louis Olagne
(L)
Vincent Poindron
(V)
Susanna Proudman
(S)
Alexis Régent
(A)
Sébastien Rivière
(S)
David Robinson
(D)
Esther Rodriguez
(E)
Sophie Roux
(S)
Perrine Smets
(P)
Doug Smith
(D)
Vincent Sobanski
(V)
Robert Spiera
(R)
Virginia Steen
(V)
Wendy Stevens
(W)
Evelyn Sutton
(E)
Benjamin Terrier
(B)
Carter Thorne
(C)
John Varga
(J)
Pearce Wilcox
(P)
Mara Cañedo Ayala
(MC)
Nora Ostbo
(N)
Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
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.
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