Long-Covid-19 Alleviation Through Learning Mindfulness Study

NCT ID: NCT07140094

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2027-11-21

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.

Detailed Description

Patients with COVID-19 disease who go on to develop Post-Acute Sequelae of SARS-CoV-2 infection (PASC) are under significant physical and psychosocial stress. Mindfulness, operationally defined as paying attention to the present moment with non-judgment and acceptance, is a candidate treatment to reduce stress in patients with PASC. Reducing stress is critical, as stress may trigger flares in PASC symptoms. Mindfulness-Based Interventions (MBIs), including Mindfulness-Based Stress Reduction, have been shown in clinical trials, and confirmed in meta-analytic studies, to improve physical and psychological indices of stress in a wide variety of clinical and non-clinical populations. Such studies suggest an MBI might be feasible and acceptable for patients with PASC and may improve PASC symptoms and quality of life. The investigator proposes to test whether an MBI among patients with PASC alleviates symptoms.

The MBI is an 8-week online intervention that consists of a series of recorded mindfulness sessions that were developed specifically for people with PASC. The goal of the MBI is to reduce stress, reduce symptoms of PASC, and improve quality of life. Symptoms are assessed through the completion of online surveys (four surveys over 6 months). All participation is remote (no in-person study visits).

Conditions

Long COVID; Long Covid19; Post-Acute COVID-19; Post-Acute COVID-19 Syndrome; Post-Acute COVID-19 Infection; COVID Long-Haul

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: OTHER

Structured mindfulness intervention

Intervention Type: 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.

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.

Group Type: OTHER

Structured mindfulness intervention

Intervention Type: 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.

Interventions

Structured mindfulness intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age > or = 18
• Willing and able to provide informed consent
• Access to the internet
• Self-reported history of SARS-CoV-2 infection
• Current symptoms attributed to PASC by participant or by participant's medical provider; ongoing symptoms that persisted >= 12 weeks after Covid-19 illness

Exclusion Criteria

• Participating in another clinical trial of an intervention for PASC symptoms
• Engaged in a structured MBI

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Deborah A. Theodore

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Theodore, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Deborah Theodore, MD

Role: CONTACT

dat2132@cumc.columbia.edu

2123058739

Facility Contacts

Deborah Theodore, MD

Role: primary

dat2132@cumc.columbia.edu

212-305-8739

References

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Reference Type: BACKGROUND

PMID: 37278994 (View on PubMed)

Other Identifiers

AAAT0564

Identifier Type: -

Identifier Source: org_study_id