Clinical trial NCT05268523: Self-Management Interventions for Long COVID-19
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: Long-term effects
Self-management
Group therapy
Telerehabilitation
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-03-07
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-Centre, multi-arm, pragmatic RCT
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Change in Brief-COPE
timeFrame: Baseline and 1-week post-intervention.
measure: Change in LOT
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Kessler Psychological Distress Scale (K10)
timeFrame: Baseline and 1-week post-intervention.
measure: Change in SSS-8
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Perceived Medical Condition Self-Management Scale
timeFrame: Baseline and 1-week post-intervention.
measure: Change in the Depression, Anxiety and Stress Scale
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Adapted Illness Intrusiveness Rating
timeFrame: Baseline and 1-week post-intervention.
measure: Change in self-reported physician visits
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Self-efficacy
timeFrame: Baseline and 1-week post-intervention.
Secondary outcomes:
measure: Feasibility: session feedback questionnaire
timeFrame: At the end of each weekly session for a duration of 8 weeks.
measure: Feasibility: Recruitment rate
timeFrame: Collected during recruitment
measure: Feasibility: Retention rate
timeFrame: Collected during recruitment and 1 week post-follow-up
measure: Feasibility: Adherence rate
timeFrame: Collected during each of the 8 session (1 sessions/week, 8 weeks)
measure: Feasibility: qualitative interview
timeFrame: 1 week post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: KITE- Toronto Rehabilitation Institute, University Health Network
name: Robin Green, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.