Self-Management Interventions for Long COVID-19

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in Brief-COPE [Срок оценки: Baseline and 1-week post-intervention.]
• Change in LOT [Срок оценки: Baseline and 1-week post-intervention.]
• Change in Kessler Psychological Distress Scale (K10) [Срок оценки: Baseline and 1-week post-intervention.]
• Change in SSS-8 [Срок оценки: Baseline and 1-week post-intervention.]
• Change in Perceived Medical Condition Self-Management Scale [Срок оценки: Baseline and 1-week post-intervention.]
• Change in the Depression, Anxiety and Stress Scale [Срок оценки: Baseline and 1-week post-intervention.]
• Change in Quality of Life Enjoyment and Satisfaction Questionnaire [Срок оценки: Baseline and 1-week post-intervention.]
• Change in Adapted Illness Intrusiveness Rating [Срок оценки: Baseline and 1-week post-intervention.]
• Change in self-reported physician visits [Срок оценки: Baseline and 1-week post-intervention.]
• Change in Self-efficacy [Срок оценки: Baseline and 1-week post-intervention.]

Вторичные конечные точки (5)

• Feasibility: session feedback questionnaire [Срок оценки: At the end of each weekly session for a duration of 8 weeks.]
• Feasibility: Recruitment rate [Срок оценки: Collected during recruitment]
• Feasibility: Retention rate [Срок оценки: Collected during recruitment and 1 week post-follow-up]
• Feasibility: Adherence rate [Срок оценки: Collected during each of the 8 session (1 sessions/week, 8 weeks)]
• Feasibility: qualitative interview [Срок оценки: 1 week post-intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Toronto Rehabilitation Institute — Toronto

Публикации

• 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

Идентификаторы

NCT: NCT05268523 · 21-5038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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