About this trial
This research is being done to study a mindfulness intervention among people who have symptoms of Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Mindfulness is defined as paying attention to the present moment with non-judgment and acceptance. Here the investigators are studying whether a mindfulness intervention can help reduce stress, reduce Long COVID symptoms, and improve quality of life among people living with Long COVID. The mindfulness intervention is a series of recorded mindfulness sessions, which were created by the study team. People who decide to take part will be randomly assigned to receive the study mindfulness intervention immediately after joining the study or to receive the study mindfulness intervention 8 weeks after joining the study. All participants will continue their usual medical care. Participants will complete online surveys to measure symptoms over time. The study will last 6 months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > or = 18
Willing and able to provide informed consent
Access to the internet
Self-reported history of SARS-CoV-2 infection
Disqualifiers
Participating in another clinical trial of an intervention for PASC symptoms
Engaged in a structured MBI
Trial design
Parallel
Treatments tested in this trial
Structured mindfulness intervention
BehavioralThe mindfulness intervention is a series of recorded mindfulness sessions, which were created by the study team. The mindfulness recordings are between two and twenty minutes long and are accessed online.
Treatment groups
Trial outcomes
Primary outcomes
Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score
This is to compare the difference between both groups at Month 2. The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health.
Secondary outcomes
Change in PROMIS Global 10 Score
The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health.
Post-Acute Sequelae of SARS-CoV-2 (PASC) Score
This study uses the PASC score defined by Thaweethai et al., JAMA, 2023. The PASC score is measured as the sum of the scores for each PASC symptom reported by a participant at the specified timepoint. See: doi:10.1001/jama.2023.8823.
Patient Health Questionnaire 9 (PHQ9) Score
The PHQ9 is a 9-item questionnaire measuring depression symptoms. The scores range from 0 to 27, with higher scores indicating greater severity.
Generalized Anxiety Disorder 7 (GAD7) Score
The GAD7 is a 7-item scale that measures anxiety symptoms. The scores range from 0 to 21, with higher scores indicating greater severity.
Sponsors and contacts
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