Long-Covid-19 Alleviation Through Learning Mindfulness Study (LONG-CALM)

Columbia University

Status: Enrolling

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

Treatments: Behavioral: Structured mindfulness intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07140094

AAAT0564

Details and patient eligibility

About

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.

Full 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).

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Group 1 - Receives Mindfulness Based Intervention (MBI) Immediately

Other group

Description:

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)

Treatment:

Behavioral: Structured mindfulness intervention

Group 2 - Receives Intervention with 8-week Delay

Other group

Description:

Group 2 will begin the study with treatment as usual; they will receive the study mindfulness intervention two months after study enrollment.

Treatment:

Behavioral: Structured mindfulness intervention