Mind-body intervention for people with Long COVID
Mind Body Intervention for Long COVID
This study is testing a mind-body program to see if it can help people with Long COVID feel better and improve their daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06045338 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a mind-body intervention in alleviating symptoms associated with Long COVID. Participants will be randomly assigned to receive either the mind-body intervention, usual care, or an active control intervention. The primary focus is on reducing somatic symptoms and improving daily functioning in individuals suffering from Long COVID. The study will also assess the impact of the intervention on specific somatic complaints compared to the control groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have tested positive for COVID-19 and experience persistent somatic symptoms.
Not a fit: Patients with clear physical diseases unrelated to COVID-19 or those over 65 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from Long COVID symptoms.
How similar studies have performed: While mind-body interventions have shown promise in other contexts, this specific approach for Long COVID is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult (≥ 18 years of age) 2. Infection with Sars-COV2 (i. e., positive antibody, antigen, or PCR testing) 3. Symptoms attributed only to COVID-19 and not to known comorbid disease (e.g., other infections, cancer, etc) 4. A somatic symptom score ≥ 10 on the SSS-8 questionnaire with involvement of at least 3 domains 5. Symptoms present at least 3 day a week for a minimum of 3 months 6. Willingness to engage in a Mind-Body intervention Exclusion Criteria: 1. Clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis 2. Hospitalization in an intensive care unit for acute COVID-19 infections 3. Age greater than 65 years 4. Diagnosis of dementia or similar cognitive impairment 5. Active addiction disorder (e.g. cocaine) that would interfere with study participation 6. Major psychiatric comorbidity (e.g., schizophrenia). Mild to moderate anxiety and depression are not considered in this category
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael Donnino, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Ashley Scafetta
- Email: ascafett@bidmc.harvard.edu
- Phone: 617-754-2882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.