Fatigue in Long COVID

NCT07697261 | Not Yet Recruiting

• 1 other identifier: Project ID-20247
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Long COVID affects about 6 in 100 people after a COVID-19 infection. It can cause ongoing problems like ongoing tiredness, muscle pain, and "brain fog." We know very little about which treatments might be helpful for long COVID. The goal of this trial is to compare two treatments for people with long COVID to try to manage their symptoms. The main question is to assess whether the Lightning Process is effective for people living with long COVID compared to activity pacing. Each person will be placed into one of the two groups randomly (by chance, like flipping a coin). Activity pacing helps people balance rest and daily activities. The Lightning Process teaches ways to change thought patterns and body responses to symptoms. We will include 100 adults with long COVID. Everything will be done online, including filling out surveys about health and daily life. The goal is to find out which approach helps people feel better and improve their daily activities.

Conditions

Long COVID

Keywords

long COVID; Lightning Process; activity pacing; post-exertional malaise; fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue (Checklist Individual Strength-Fatigue)

  The primary outcome will be the mean change in fatigue scores between Lightning Process and activity pacing group at 12 months post randomization. This will be assessed on the fatigue domain of the 8-item Checklist Individual Strength (CIS-fatigue) at 12 months follow-up. The CIS-fatigue domain consists of 8 items with a total score ranging from 8 to 56, with higher scores indicating more severe fatigue.

  12 months

Secondary Outcomes (10)

• Respiratory function (Dyspnea-12)

  6 months, 9 months, and 12 months

• Post Exertional Malaise (De Paul Symptom Questionnaire)

  Baseline, 6 months, 9 months, and 12 months

• Daily Pain (Brief Pain Inventory Short Form)

  6 months, 9 months, and 12 months

• Fatigue (Checklist Individual Strength-Fatigue)

  6 months and 9 months

• Physical function (SF-12)

  Baseline, 6 months, 9 months, and 12 months

Study Arms (2)

Lightning Process

EXPERIMENTAL

Lightning Process is a mind body intervention that focusses on identifying and interrupting negative thoughts that may affect fatigue.

Behavioral: Lightning Process

Activity pacing

ACTIVE COMPARATOR

Activity pacing is a self-management strategy that balances activity and rest to manage fatigue, allowing individuals to maintain consistent energy levels throughout the day.

Other: Activity Pacing

Interventions

Lightning Process BEHAVIORAL

LP is a mind body intervention which is delivered over 3 consecutive days to individuals or in groups via video technology. The sessions are approximately 4 hours long. Experienced LP practitioners will deliver the LP intervention remotely and individually. The intervention is comprised of a preparation phase, core sessions, and follow-up. Preparation consists of an audio home-study module (about 4 hours total) and about 1 hour of preparatory coaching by telephone or videoconference in the days to weeks before delivery of the LP intervention to orient participants to the approach and address any questions.

Lightning Process

Activity Pacing OTHER

Activity Pacing, a self-management strategy that balances activity and rest to manage fatigue, allowing individuals to maintain consistent energy levels throughout the day. The aim of activity pacing is to avoid symptom exacerbations whilst achieving as much as possible with limited energy. Pacing focusses on developing awareness not only of the symptoms but also more subtle indicators that herald a future exacerbation of symptoms (listening to your body) and becoming aware of effect of activity or lack of rest on disability. Senior occupational therapy students will deliver activity pacing remotely and individually by videoconference.

Activity pacing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 65 years
• Meeting the WHO clinical case definition for long COVID and
• Self-reported experiencing long COVID symptoms such as fatigue, muscle pain, and brain fog.
• Reporting a minimum score of ≥35 on the Checklist Individual Strength CIS-fatigue domain.
• Able to speak and read English
• Scoring higher in contemplation, action or maintenance scores than the precontemplation phase on the readiness to change questionnaire
• Provides consent for study participation.
• Consistent access to an internet-connected device (e.g., smartphone, tablet, laptop) that can facilitate access to the study interventions.

You may not qualify if:

• Long COVID participants whose presentation is primarily restricted to anosmia.
• Participants with Post-Intensive Care Syndrome (PICS) or serious organic sequelae of COVID-19, such as structural lung injury attributable to mechanical ventilation or other organ damage requiring ongoing specialist management.
• Participants who will not be able to attend intervention sessions or follow up visits due to anticipated significant life changes or relocation.
• Unable to provide informed consent (e.g. cognitive disability, language barrier)
• Co-morbidities that likely to impair function for as long or longer than long COVID
• Current participation in psychotherapy, structured physical rehabilitation (e.g., physiotherapy or occupational therapy), or another trial that does not permit co-enrollment.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Academic Health Sciences Organization: collaborator

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Dr. Jason Busse, PhD, Professor

CONTACT

(905) 525-9140; bussejw@mcmaster.ca

Rozina Thobani, MSc

CONTACT

thobar1@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the interventions under study, the trial is necessarily open-label. Blinding of participants, LP instructors and occupational therapists is not possible. The study team members responsible for data analysis and interpretation will remain blinded to treatment allocation until completion of the primary analyses and interpretation of results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This will be a pragmatic, multicenter, decentralized, international, parallel group, open-label randomized controlled trial. Participants living with long COVID will be randomized to receive either Lightning Process or activity pacing.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be publicly available upon study commencement.
• Access Criteria: Anonymized data will be shared upon reasonable request from other researchers for use in specific research projects on long COVID when the main analyses are completed and published.