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.
| Original language | English (US) |
|---|---|
| Article number | 110132 |
| Journal | Journal of Psychosomatic Research |
| Volume | 135 |
| DOIs | |
| State | Published - Aug 2020 |
Funding
The SPIN-CHAT Trial was funded by the McGill Interdisciplinary Initiative in Infection and Immunity Emergency COVID-19 Research Fund ; Scleroderma Canada , made possible by an educational grant for patient support programming from Boehringer Ingelheim ; the Scleroderma Society of Ontario ; Scleroderma Manitoba ; Scleroderma Atlantic ; Scleroderma Australia ; Scleroderma New South Wales ; Scleroderma Victoria ; Scleroderma Queensland ; Scleroderma SASK ; the Scleroderma Association of BC ; and Scl\u00E9rodermie Qu\u00E9bec . Drs. Wu and Levis were supported by Fonds de recherche du Qu\u00E9bec \u2013 Sant\u00E9 Postdoctoral Training Fellowships , Mr. Harb and Ms. Carboni-Jim\u00E9nez 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. The SPIN-CHAT Trial was funded by the McGill Interdisciplinary Initiative in Infection and Immunity Emergency COVID-19 Research Fund; Scleroderma Canada, made possible by an educational grant for patient support programming from Boehringer Ingelheim; the Scleroderma Society of Ontario; Scleroderma Manitoba; Scleroderma Atlantic; Scleroderma Australia; Scleroderma New South Wales; Scleroderma Victoria; Scleroderma Queensland; Scleroderma SASK; the Scleroderma Association of BC; and Scl?rodermie Qu?bec. Drs. Wu and Levis were supported by Fonds de recherche du Qu?bec ? Sant? Postdoctoral Training Fellowships, Mr. Harb and Ms. Carboni-Jim?nez 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.
Keywords
- Anxiety
- COVID-19
- Coronavirus
- Mental health
- RCT
- Scleroderma
- Systemic sclerosis
- Trial
ASJC Scopus subject areas
- Clinical Psychology
- Psychiatry and Mental health
