Long-Covid-19 Alleviation Through Learning Mindfulness Study (LONG-CALM)
Brief Summary
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.
Enrollment (Estimated)
400
Intervention
Group 1 - Receives Mindfulness Based Intervention (MBI) Immediately
Primary Outcome Measures
Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score
Secondary Outcome Measures
Deborah Theodore, MD, Columbia University
clinicaltrials.gov
Brief Summary
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.
Enrollment (Estimated)
400
Intervention
Group 1 - Receives Mindfulness Based Intervention (MBI) Immediately
- The 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.
Primary Outcome Measures
Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score
Secondary Outcome Measures
- Change in PROMIS Global 10 Score
- Post-Acute Sequelae of SARS-CoV-2 (PASC) Score
- Patient Health Questionnaire 9 (PHQ9) Score
- Generalized Anxiety Disorder 7 (GAD7) Score
- Impact of Event 6 (IES-6) Scores
- State Mindfulness Scale for Physical Activity Score
- Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score
Deborah Theodore, MD, Columbia University
ClinicalTrials.gov
clinicaltrials.gov