Long-Covid-19 Alleviation Through Learning Mindfulness Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Structured mindfulness intervention

    Behavioral

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Group 1 - Receives Mindfulness Based Intervention (MBI) ImmediatelyOther 1 intervention
Group B: Group 2 - Receives Intervention with 8-week DelayOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Month 2

Secondary outcomes

1

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.

Time frame
Months 1, 2, 6
2

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.

Time frame
Months 1, 2, 6
3

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.

Time frame
Months 1, 2, 6
4

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.

Time frame
Months 1, 2, 6

Other outcomes

Sponsors and contacts

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