Long-Covid-19 Alleviation Through Learning Mindfulness Study
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT07140094
- Status
- Recruiting
Conditions
- COVID Long-Haul
- Long COVID
- Long Covid19
- Post-Acute COVID-19
- Post-Acute COVID-19 Infection
- Post-Acute COVID-19 Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- 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.
Study Details
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.
Key Dates
- Start date
- May 21, 2024
- Status verified
- Aug 2025
- Primary completion
- May 21, 2027
- Completion
- Nov 21, 2027
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Other: Group 1 - Receives Mindfulness Based Intervention (MBI) ImmediatelyGroup 1 participants will receive the study mindfulness intervention at the beginning of the study, along with their regular treatment as usual (through their medical providers)
- Other: Group 2 - Receives Intervention with 8-week DelayGroup 2 will begin the study with treatment as usual; they will receive the study mindfulness intervention two months after study enrollment.
Primary Outcome Measure
Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score [ Time Frame: Month 2 ]
Central Contacts
- Deborah Theodore, MD2123058739
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University | New York | New York | 10032 |
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