Mindfulness for Long COVID Syndrome

(LONG-CALM Trial)

Overseen By Deborah Theodore, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Other PASC trial, Structured MBI

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mindfulness can improve well-being for individuals with Long COVID. Participants will listen to recorded mindfulness sessions (structured mindfulness intervention) to assess their impact on stress reduction and quality of life. Some participants will begin the sessions immediately, while others will start after eight weeks, all while continuing their usual medical care. The study seeks individuals who continue to experience COVID-19-related symptoms at least 12 weeks after their illness began and have internet access. As an unphased trial, this study offers a unique opportunity to explore mindfulness as a potential method to enhance well-being for those with Long COVID.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop taking your current medications. Participants will continue their usual medical care while taking part in the study.

What prior data suggests that this mindfulness intervention is safe for people with Long COVID?

Research has shown that mindfulness activities are generally safe and manageable. In past studies, participants who practiced mindfulness reported reduced anxiety and depression. They also experienced less physical and mental fatigue, along with decreased muscle and joint pain. These studies have not linked mindfulness to any serious side effects.

Mindfulness involves focusing on the present moment with an open and accepting attitude. It does not require medications or medical procedures, reducing the risk of physical side effects. For those considering participation, safety information from similar mindfulness activities appears encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness for Long COVID because it offers a non-pharmaceutical approach that may help manage symptoms like fatigue and cognitive difficulties. Unlike traditional treatments that often focus on medication, mindfulness practices aim to enhance the mind-body connection, potentially reducing stress and promoting overall well-being. This intervention can be easily integrated into daily life and may provide a sustainable, low-risk option for people looking for complementary ways to address their Long COVID symptoms.

What evidence suggests that this mindfulness intervention might be an effective treatment for Long COVID?

Research has shown that mindfulness meditation can help alleviate Long COVID symptoms. Studies have found it reduces tiredness and improves sleep for those with post-viral infections. Practitioners of mindfulness reported feeling less physically and mentally fatigued and experienced less muscle and joint pain. Additionally, mindfulness can reduce feelings of depression and anxiety, leading to an improved mood. In this trial, participants in Group 1 will receive the mindfulness intervention immediately, while Group 2 will receive it after an 8-week delay. These findings suggest that mindfulness could be beneficial for managing Long COVID symptoms. ^{4 5 6 7 8}

Who Is on the Research Team?

Deborah Theodore, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals experiencing Long COVID symptoms, also known as Post-Acute Sequelae of SARS-CoV-2 infection (PASC). Participants will engage in a structured mindfulness program and must be willing to complete online surveys. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am 18 years old or older.

Access to the internet

Willing and able to provide informed consent

Exclusion Criteria

Participating in another clinical trial of an intervention for PASC symptoms

I am participating in a structured mind-body program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness-Based Intervention (MBI)

Participants receive an 8-week online mindfulness intervention to reduce stress and improve quality of life

8 weeks

All participation is remote (no in-person study visits)

Follow-up

Participants are monitored for changes in symptoms and quality of life through online surveys

4 months

4 online surveys over 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Structured mindfulness intervention

Trial Overview The study tests whether a series of recorded mindfulness sessions can alleviate stress, reduce Long COVID symptoms, and improve quality of life. Participants are randomly assigned to start the intervention immediately or after an 8-week delay while continuing usual medical care.

How Is the Trial Designed?

Group I: Group 2 - Receives Intervention with 8-week Delay Experimental Treatment 1 Intervention

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

Group II: Group 1 - Receives Mindfulness Based Intervention (MBI) Immediately Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9653042/

Mindfulness Meditation Interventions for Long COVID Meditation has been found to reduce fatigue and unrefreshing sleep, and for those with post-viral infections, it has enhanced immunity, and reduced ...

2. tandfonline.com tandfonline.com/doi/full/10.2147/NDT.S379653

Mindfulness Meditation Interventions for Long COVID Meditation has been found to reduce fatigue and unrefreshing sleep, and for those with post-viral infections, it has enhanced immunity, and reduced ...

3. mdpi.com mdpi.com/1660-4601/20/2/1361

Positive Impacts of a Four-Week Neuro-Meditation ... Patients receiving MBI showed significant decreases in physical and mental fatigue, muscle and joint pain, symptoms of depression and anxiety, and mood ...

4. clinicaltrial.be clinicaltrial.be/en/details/559271?per_page=100&condition[0]=PASC%20Post%20Acute%20Sequelae%20of%20COVID%2019&condition[1]=Long%20COVID&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Long-Covid-19 Alleviation Through Learning Mindfulness ... The MBI is an 8-week online intervention that consists of a series of recorded mindfulness sessions that were developed specifically for people ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775841/

Effectiveness of Meditation-based Interventions on Health ... This review offers compelling evidence supporting the effectiveness of MBIs in alleviating these five prevalent disorders resulting from the COVID-19 pandemic.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06492590

Long COVID-19 Intervention (COVIDL/MIQoL) The goal of this clinical trial is to assess the effectiveness of a multicomponent intervention in individuals with Long COVID. The main questions it aims ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12279302/

The Effects of a Mindfulness-Based Intervention on ... In this study, we report on the utility of a mindfulness-based intervention on levels of anxiety and depression in a long-COVID population. Our ...

8. autoimmuneinstitute.org autoimmuneinstitute.org/covid_timeline/mindfulness-therapy-trial-for-long-covid-begins/

Mindfulness Therapy Trial for Long COVID Begins Columbia University has launched a clinical trial to test whether structured mindfulness practices can ease symptoms of Long COVID.