Official Title
Interventions to Teach Self-management Skills for Persisting Symptoms of COVID-19: Minimizing Impact of Symptoms on Everyday Functioning and on Healthcare Usage/utilization
Brief Summary

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

Detailed Description

After a COVID-19 infection, more than 75% of patients report ongoing somatic, cognitive,
and psychiatric symptoms. At this time, research is needed 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.

Recruiting
COVID-19

Behavioral: Education and Strategies Intervention

Sessions will be led by registered therapists and clinicians in the fields of psychology,
rheumatology, cardiology and neurology. The sessions will be comprised of educational
presentations on the nature of persisting symptoms after COVID-19 and associated
recommendations for self-management.

Behavioral: Mindfulness Skills Intervention

The Mindfulness Skills Intervention is an 8-week program designed to provide an
introduction to some basic mindfulness skills. Each session begins with a brief breath
focus practice followed by discussion of the experience and sharing/discussion of the
previous week including participants' experiences. Each session also includes some
didactics, and a new, related mindfulness skill is introduced and practiced, followed by
another discussion.

Eligibility Criteria

Inclusion Criteria:

- Clinically diagnosed Long-COVID plus PCR positivity with and without hospitalization

- 3-12 months post-diagnosis of COVID-19

- >2 self-reported persisting symptoms in >1 mood, cognitive and/or somatic symptom
domain

- Age >18

- English speaking

- Private access to computer/internet

Exclusion Criteria:

- Acute ventilator support

- Diagnosed dementia

- Past/present history of psychotic illness or mania and, because of potential overlap
in symptoms, diagnosis of chronic fatigue syndrome, fibromyalgia, chronic lyme
disease or traumatic brain injury

- Long-COVID symptom severity (i.e., physical, cognitive, emotional symptoms) at a
level that would significantly interfere with attendance/adherence to the
intervention protocol

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Canada
Locations

Toronto Rehabilitation Institute
Toronto, Ontario, Canada

Contacts

Julia Rybkina, MSc
416-597-3422 - 7651
julia.rybkina@uhn.ca

Nithin Jacob, MSc
416-597-3422
helpscovid@uhn.ca

Robin Green, PhD, Principal Investigator
KITE- Toronto Rehabilitation Institute, University Health Network

Toronto Rehabilitation Institute
NCT Number
Keywords
Long-term effects
Self-Management
Group therapy
telerehabilitation
MeSH Terms
COVID-19