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 — 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.

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) Immediately
    Group 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 Delay
    Group 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

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10032
Deborah Theodore, MD
212-305-8739

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