Fatigue in Long COVID

The COVID-19 pandemic presented an unprecedented global health crisis, affecting millions globally and causing significant health and economic consequences. Although most people recover from acute SARS-CoV-2 infection, a substantial minority, approximately 6 to 15%, develop persistent symptoms that last for months and impair daily function, commonly referred to as post-COVID-19 condition or long COVID. Common symptoms of long COVID include fatigue, myalgia, dyspnea, sleep disturbance, and cognitive dysfunction ("brain fog"). The prevalence of long COVID is difficult to establish because most symptoms are nonspecific and many data sources rely on study designs that cannot confidently attribute symptoms to prior SARS-CoV-2 infection. Despite this uncertainty, converging evidence points to a large global burden, with \>65 million people estimated to be living with functional limitations attributed to long COVID. The Lightning Process (LP), is a mind-body training program that is hypothesized to help individuals to develop a conscious influence on their level of functioning, using practical tools such as discussion, gentle movement and meditation-like techniques. Emerging evidence suggests that gradually re-engaging long COVID patients in physical activation and modifying unhelpful beliefs may promote recovery. There are currently no established treatments for long COVID, and patients often use activity pacing to manage their symptoms. The purpose of this trial is to establish the efficacy and safety of LP vs. activity pacing in adults living with long COVID. We hypothesize that in our trial, people randomized to LP will report greater improvement in fatigue compared to those receiving activity pacing. Our trial will enroll people living with long COVID who are motivated and show willingness to change their condition through intervention. The trial will assess whether, among adults living with long COVID (post COVID-19 condition) and persistent, function limiting symptoms, LP improves fatigue and other patient important outcomes, compared to activity pacing.

The primary objective is to assess the effect of LP vs. activity pacing on fatigue among adults with long COVID.

The secondary objectives are to assess the effect of LP vs. activity pacing on

* Physical functioning * Pain severity * Post exertional malaise * Health related quality of life * Somatic symptom severity * Functional impairment * Respiratory function * Adverse events and serious adverse events

Both LP and pacing interventions span 26 weeks. Patients assigned to the LP intervention will complete a brief preparatory phase, then attend three consecutive core sessions. The LP protocol includes two follow-up calls one week apart and a booster call at week 26. Patients assigned to the pacing intervention complete 15 sessions over 24 weeks-four weekly sessions, then sessions every two weeks until week 26.

Participants will complete outcome measures at 6 months, coinciding with the immediate the end of the intervention, and at 9 and 12 months. The post-treatment time point estimates the proximal effect of LP compared to pacing, where contamination is lowest, co-interventions are least likely to diverge across arms, and any harms (e.g., post-exertional worsening) are most plausibly related to the assigned strategy.

• Respiratory function (Dyspnea-12) [Срок оценки: 6 months, 9 months, and 12 months]
• Post Exertional Malaise (De Paul Symptom Questionnaire) [Срок оценки: Baseline, 6 months, 9 months, and 12 months]
• Daily Pain (Brief Pain Inventory Short Form) [Срок оценки: 6 months, 9 months, and 12 months]
• Fatigue (Checklist Individual Strength-Fatigue) [Срок оценки: 6 months and 9 months]
• Physical function (SF-12) [Срок оценки: Baseline, 6 months, 9 months, and 12 months]
• Health related quality of life (EuroQol-5 Dimensions) [Срок оценки: Baseline, 6 months, 9 months, and 12 months]
• Severity of somatic symptoms (Patient Health Questionnaire-15) [Срок оценки: 6 months, 9 months, and 12 months]
• Functional impairment (Work and Social Adjustment Scale) [Срок оценки: 6 months, 9 months, and 12 months]
• Adverse Events (AEs) [Срок оценки: Up to 12 months]
• Serious Adverse Events (SAEs) [Срок оценки: Up to 12 months]