Mind Body Therapy for Long COVID

Overseen By Michale Donnino, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Age, Organic disease, Severe COVID, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mind-body program, originally designed for chronic back pain, can relieve symptoms of Long Covid. It includes group sessions and a day-long retreat to determine if this approach can ease fatigue, headaches, and chest pain. Individuals who developed new symptoms after recovering from COVID-19 and have experienced these issues for at least a month may be suitable candidates. The trial seeks participants open to trying mind-body techniques. As an unphased trial, this study provides a unique opportunity to explore innovative mind-body techniques that could enhance well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mind-body program is safe for individuals with COVID Long Haul Syndrome?

Research shows that mind-body therapies, like meditation and yoga, are usually well-tolerated. These treatments focus on the interaction between mind and body to enhance health. Since they don't involve drugs, they typically cause fewer side effects than medication-based treatments.

For the specific mind-body program being tested for Long COVID, direct safety data is not yet available. However, this therapy adapts a program used for chronic back pain, suggesting safety for other conditions. Participants in similar programs often engage in group sessions and personal learning, which generally do not cause harm.

This trial is in its early stages and primarily assesses the program's feasibility. As a result, detailed safety data might not yet be available. However, mind-body therapies are generally considered safe and have been used for other conditions without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mind Body Syndrome Therapy for Long Covid because it tackles the condition through a holistic approach rather than conventional medical treatments like medications or physical therapy. Unlike standard therapies that focus primarily on physical symptoms, this therapy incorporates interactive group sessions, educational components, and a unique day-long retreat to address both mental and physical aspects of long-haul COVID-19. By integrating mind-body techniques, this therapy aims to provide a comprehensive strategy to alleviate symptoms, potentially offering relief to those who haven't found success with traditional treatments.

What evidence suggests that Mind Body Syndrome Therapy is effective for Long Covid?

Research has shown that mind-body therapies might help manage Long COVID symptoms such as tiredness, trouble concentrating, and anxiety. These therapies have also been used successfully for chronic pain, suggesting they might alleviate the various physical symptoms Long COVID patients face. Although only about 27.3% to 33.8% of people in a general survey found mind-body approaches very effective, these therapies remain promising because they address both mental and physical health. In this trial, participants will receive Mind Body Syndrome Therapy for Long COVID to determine if these methods can provide relief. ^{3 6 7 8 9}

Who Is on the Research Team?

Michael Donnino, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Minimum of at least 12 weeks after the end of the acute phase of COVID-19 infection

Persistence of symptoms for a least 1 month with no identified other organic etiology

Symptoms present for a minimum of 4 days a week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week mind-body intervention program with biweekly group sessions and a day-long retreat

12 weeks

Biweekly group sessions, 1 day-long retreat

Follow-up

Participants are monitored for changes in somatic symptoms, pain, anxiety, fatigue, dyspnea, brain fog, and physical functioning

1 week

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mind Body Syndrome Therapy for Long Covid

How Is the Trial Designed?

Group I: Mind Body Syndrome Therapy for Long Covid Experimental Treatment 1 Intervention

The participants will receive an initial one-on-one interview, followed by 1 to 2 hour biweekly group interactive, educational sessions for 12 weeks. This program also includes a day-long "retreat" at the end of the required course period. Participants will also be provided reading materials to study during the intervention period

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

A community-based Long Covid support service combining psycho-educational and mind-body approaches showed positive outcomes, with participants reporting improvements in mental, physical, emotional, and spiritual wellbeing as measured by the Warwick Holistic Health Questionnaire.

Out of 25 participants, 16 showed significant improvement in their wellbeing scores after engaging with the service, indicating that this complementary approach is beneficial for individuals experiencing health challenges from Long Covid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A service evaluation of a community project combining psychoeducation and mind-body complementary approaches to support those with long covid in the UK. Brough, DN., Abel, S., Priddle, L.[2023]

Intranasal immunotherapy using bioactive substances from M2 macrophages was well tolerated and showed significant improvement in olfactory function in 7 patients with long-term post-COVID-19 hyposmia, with results measured at baseline and follow-ups of 1 and 6-12 months.

At the 6- to 12-month follow-up, 5 out of 7 patients reported high satisfaction with their restored ability to perceive and recognize odors, indicating that this therapy may be an effective treatment for chronic olfactory impairment following COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal immunotherapy with M2 macrophage soluble factors in post-COVID hyposmia: A pilot study. Shevela, EY., Davydova, MN., Meledina, IV., et al.[2023]

A 19-year-old male with long COVID developed symptoms consistent with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and was treated using established ME/CFS management strategies, leading to significant symptom improvement over 30 months.

The case suggests that treatment approaches for ME/CFS, including physical therapy and targeted medications, may be beneficial for some patients suffering from long COVID, particularly those with overlapping symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Study of Successful Application of the Principles of ME/CFS Care to an Individual with Long COVID. Petracek, LS., Broussard, CA., Swope, RL., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11418572/

Long COVID or Post-Acute Sequelae of SARS-CoV-2 Infection ...

Long COVID/PASC occurs in 10–20% of patients infected with SARS-CoV-2. The most common symptoms include fatigue, cognitive impairment (brain fog), and shortness ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9870628/

Patients' Experiences With Therapeutic Approaches for Post ...

Only 27.3% and 33.8% of patients rating these approaches, respectively, reported their effectiveness to be good or very good (4 or 5 on the 5-point scale), ...

3.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2805540

Development of a Definition of Postacute Sequelae ...

This study aims to develop a definition of postacute sequelae of SARS-CoV-2 infection (PASC) based on self-reported symptoms and describe ...

4.

psychiatryonline.org

psychiatryonline.org/doi/10.1176/appi.neuropsych.21070193

Post-Acute Sequelae of SARS-CoV-2 Infection

The most prevalent symptoms after COVID-19 infection were fatigue, “brain fog,” headache, anxiety, and sleep issues. Attention and executive function were ...

5.

nyaspubs.onlinelibrary.wiley.com

nyaspubs.onlinelibrary.wiley.com/doi/10.1111/nyas.15132

Long COVID and post‐acute sequelae of SARS‐CoV‐2 ...

In this report, we present insights from the talks and workshops presented during this meeting and highlight key themes regarding what researchers have ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11500513/

Long COVID and post-acute sequelae of SARS-CoV-2 ...

In this report, we present insights from the talks and workshops presented during this meeting and highlight key themes regarding what researchers have ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06045338

NCT06045338 | Mind Body Intervention for Long COVID-19

The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants.

8.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0140673

Post-Acute COVID-19 Syndrome (DBCOND0140673)

Associated Data ; NCT06045338. Mind Body Intervention for Long COVID-19, No drug interventions ; NCT05373043. Long-term COVID and Rehabilitation, No drug ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11363684/

Postacute Sequelae of COVID (PASC or Long COVID)

PASC is a defined syndrome with ongoing, relapsing, or new conditions after documented or diagnosed infection with SARS-CoV-2.