Self-Management Interventions for Long COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Education and Strategies Intervention, Mindfulness Skills Intervention.
- Who it may be relevant to
- Registry conditions: COVID-19. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Change in Brief-COPE [Time frame: Baseline and 1-week post-intervention.]
- Change in LOT [Time frame: Baseline and 1-week post-intervention.]
- Change in Kessler Psychological Distress Scale (K10) [Time frame: Baseline and 1-week post-intervention.]
- Change in SSS-8 [Time frame: Baseline and 1-week post-intervention.]
- Change in Perceived Medical Condition Self-Management Scale [Time frame: Baseline and 1-week post-intervention.]
- Change in the Depression, Anxiety and Stress Scale [Time frame: Baseline and 1-week post-intervention.]
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire [Time frame: Baseline and 1-week post-intervention.]
- Change in Adapted Illness Intrusiveness Rating [Time frame: Baseline and 1-week post-intervention.]
- Change in self-reported physician visits [Time frame: Baseline and 1-week post-intervention.]
- Change in Self-efficacy [Time frame: Baseline and 1-week post-intervention.]
Secondary outcome measures (5)
- Feasibility: session feedback questionnaire [Time frame: At the end of each weekly session for a duration of 8 weeks.]
- Feasibility: Recruitment rate [Time frame: Collected during recruitment]
- Feasibility: Retention rate [Time frame: Collected during recruitment and 1 week post-follow-up]
- Feasibility: Adherence rate [Time frame: Collected during each of the 8 session (1 sessions/week, 8 weeks)]
- Feasibility: qualitative interview [Time frame: 1 week post-intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Toronto Rehabilitation Institute — Toronto
Publications
- Gorna R, MacDermott N, Rayner C, O'Hara M, Evans S, Agyen L, Nutland W, Rogers N, Hastie C. Long COVID guidelines need to reflect lived experience. Lancet. 2021 Feb 6;397(10273):455-457. doi: 10.1016/S0140-6736(20)32705-7. Epub 2020 Dec 23. No abstract available. PMID 33357467
- Mahase E. Covid-19: What do we know about "long covid"? BMJ. 2020 Jul 14;370:m2815. doi: 10.1136/bmj.m2815. No abstract available. PMID 32665317
- Sykes DL, Holdsworth L, Jawad N, Gunasekera P, Morice AH, Crooks MG. Post-COVID-19 Symptom Burden: What is Long-COVID and How Should We Manage It? Lung. 2021 Apr;199(2):113-119. doi: 10.1007/s00408-021-00423-z. Epub 2021 Feb 11. PMID 33569660
- Taquet M, Geddes JR, Husain M, Luciano S, Harrison PJ. 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records. Lancet Psychiatry. 2021 May;8(5):416-427. doi: 10.1016/S2215-0366(21)00084-5. Epub 2021 Apr 6. PMID 33836148
- Bryson WJ. Long-term health-related quality of life concerns related to the COVID-19 pandemic: a call to action. Qual Life Res. 2021 Mar;30(3):643-645. doi: 10.1007/s11136-020-02677-1. Epub 2020 Oct 18. PMID 33073307
- Rybkina J, Jacob N, Colella B, Gold D, Stewart DE, Ruttan LA, Meusel LC, McAndrews MP, Abbey S, Green R. Self-managing symptoms of Long COVID: an education and strategies research protocol. Front Public Health. 2024 Feb 7;12:1106578. doi: 10.3389/fpubh.2024.1106578. eCollection 2024. PMID 38384879
Identifiers
NCT: NCT05268523 · 21-5038