KITE Research Institute, Toronto Rehabilitation Institute-University Health Network, Toronto, ON, Canada.
Telerehab Centre for Acquired Brain Injury, Toronto Rehabilitation Institute-University Centre, University Health Network, Toronto, ON, Canada.
Front Public Health. 2024 Feb 7;12:1106578. doi: 10.3389/fpubh.2024.1106578. eCollection 2024.
Post-acute sequelae of SARS-COV-2 (PASC) is growing in prevalence, and involves symptoms originating from the central neurological, cardiovascular, respiratory, gastrointestinal, autonomic nervous, or immune systems. There are non-specific symptoms such as fatigue, headaches, and brain fog, which cannot be ascribed to a single system. PASC places a notable strain on our healthcare system, which is already laden with a large number of acute-COVID-19 patients. Furthermore, it impedes social, academic and vocational functioning, and impacts family life, relationships, and work/financial life. The treatment for PASC needs to target this non-specific etiology and wide-ranging sequelae. In conditions similar to PASC, such as "chemo brain," and prolonged symptoms of concussion, the non-specific symptoms have shown to be effectively managed through and interventions. However, such interventions have yet to be empirically evaluated in PASC to our knowledge. In response to this gap, we have developed a virtual education intervention synthesized by psychiatrists and clinical psychologists for the current study. We will undertake a two-phase randomized controlled trial to determine the feasibility (Phase 1; = 90) and efficacy (Phase 2; sample sized based on phase 1 results) of the novel 8 week Education and Self-Management Strategies group compared to a mindfulness skills program, both delivered virtually. Main outcomes include confidence/ability to self-manage symptoms, quality of life, and healthcare utilization. This study stands to mitigate the deleterious intrusiveness of symptoms on everyday life in patients with PASC, and may also help to reduce the impact of PASC on the healthcare system. https://classic.clinicaltrials.gov/ct2/show/NCT05268523; identifier NCT05268523.
SARS-CoV-2 的新冠后遗症(PASC)的发病率正在上升,涉及从中枢神经系统、心血管系统、呼吸系统、胃肠道系统、自主神经系统或免疫系统起源的症状。还有一些非特异性症状,如疲劳、头痛和脑雾,这些症状不能归因于单一系统。PASC 给我们的医疗系统带来了显著的压力,而我们的医疗系统已经有大量的急性 COVID-19 患者。此外,它还妨碍了社会、学术和职业功能,影响了家庭生活、人际关系和工作/财务生活。PASC 的治疗需要针对这种非特异性病因和广泛的后遗症。在类似于 PASC 的情况下,如“化疗脑”和 concussion 的长期症状,已经表明通过 和 干预可以有效地管理这些非特异性症状。然而,据我们所知,这些干预措施尚未在 PASC 中进行实证评估。针对这一空白,我们已经由精神科医生和临床心理学家为当前研究综合开发了一种虚拟教育干预措施。我们将进行一项两阶段随机对照试验,以确定新型 8 周教育和自我管理策略组(与正念技能计划相比)的可行性(第 1 阶段;n=90)和疗效(基于第 1 阶段结果确定样本量的第 2 阶段),两者均通过虚拟方式提供。主要结局包括自我管理症状的信心/能力、生活质量和医疗保健利用。本研究旨在减轻 PASC 患者日常生活中症状的有害侵入性,也可能有助于减轻 PASC 对医疗系统的影响。https://classic.clinicaltrials.gov/ct2/show/NCT05268523; identifier NCT05268523.