Mind Body Intervention for COVID-19 Long Haul Syndrome

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

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a mind-body program can help people with long-term COVID symptoms feel better. The program includes classes on understanding pain, reducing sensitivity to it, expressing emotions, and lowering stress. It targets patients who have ongoing symptoms without visible tissue damage.

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 data supports the effectiveness of Mind Body Syndrome Therapy for Long Covid?

Research suggests that mind-body approaches, including mindfulness meditation and neuro-meditation, can improve cognitive function, reduce stress, and enhance overall well-being in Long COVID patients. These therapies have shown promise in managing symptoms similar to those of Long COVID, such as fatigue and cognitive impairment, by improving mental health and reducing inflammation. ^{1 2 3 4 5}

Is Mind Body Syndrome Therapy for Long Covid safe for humans?

The research on similar therapies, like neuro-meditation and intranasal immunotherapy, suggests they are generally safe and well-tolerated in humans, with no significant adverse effects reported. ^{3 6 7 8 9}

How does Mind Body Syndrome Therapy for Long Covid differ from other treatments?

Mind Body Syndrome Therapy for Long Covid is unique because it focuses on mind-body techniques like meditation and sound therapy to improve cognitive function and mental health, rather than relying on medication. This approach is novel as it addresses the psychological and cognitive aspects of Long Covid, which are often overlooked in traditional treatments. ^{1 2 3 10 11}

Research Team

Michael Donnino, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

Adult patient ≥ 18 years old

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

Timeline

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)

Treatment Details

Interventions

• Mind Body Syndrome Therapy for Long Covid

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an amygdala and insula retraining program combined with mindfulness training to improve the quality of life in patients with long COVID: a randomized controlled trial protocol. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Positive Impacts of a Four-Week Neuro-Meditation Program on Cognitive Function in Post-Acute Sequelae of COVID-19 Patients: A Randomized Controlled Trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Case Study of Successful Application of the Principles of ME/CFS Care to an Individual with Long COVID. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation Interventions for Long COVID: Biobehavioral Gene Expression and Neuroimmune Functioning. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Protracted stress-induced hypocortisolemia may account for the clinical and immune manifestations of Long COVID. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Intranasal immunotherapy with M2 macrophage soluble factors in post-COVID hyposmia: A pilot study. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Rapid deployment of virtual mind-body interventions during the COVID-19 outbreak: feasibility, acceptability, and implications for future care. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The results of a unique dietary supplement (nutraceutical formulation) used to treat the symptoms of long-haul COVID. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Transforming Trauma With Lifestyle Medicine. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Psychophysical therapy and underlying neuroendocrine mechanisms for the rehabilitation of long COVID-19. [2023]