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Clinical Trial Summary

The purpose of this study is to investigate and compare the feasibility and efficacy of two group-based interventions (education vs. mindfulness) to help self-manage Long-COVID symptoms.


Clinical Trial Description

After a COVID-19 infection, more than 75% of patients report ongoing somatic, cognitive, and psychiatric symptoms. At this time, we need research to help develop treatments that limit the impact of these symptoms on people who have had COVID-19. The present study investigates the feasibility and efficacy of two group-based interventions in a single-centre, 3-arm, pragmatic RCT comprising (i) an Education Intervention Group arm, (ii) a Mindfulness Skills Intervention Group arm, and (iii) a No-Treatment Control Group arm. Phase 1 is a pilot RCT and will employ a mixed methods design with qualitative post-treatment interviews in a subset of participants in the Education Intervention Group arm only. Phase 2 is a full-scale, quantitative-only RCT, with refinements and power analysis based on the results of Phase 1. Sessions of both groups are delivered by licensed therapists and clinicians. Sessions last 1.5 hours per week for 8 weeks, with 10-15 patients/group in an online format. The Education group participants will learn about the nature of Long-COVID symptoms and discuss strategies for self-care/self-management of symptoms in recovery. The Mindfulness Skills Intervention group participants will receive an introduction to some basic mindfulness skills and practice strategies such as Mindfulness of Breath, Body, Sounds, Thoughts, and Choiceless Awareness. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05268523
Study type Interventional
Source Toronto Rehabilitation Institute
Contact Julia Rybkina, MSc
Phone 416-597-3422
Email julia.rybkina@uhn.ca
Status Recruiting
Phase Phase 1/Phase 2
Start date November 23, 2021
Completion date September 1, 2022

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