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Mind Body Intervention for Long COVID-19

NCT06045338 · Beth Israel Deaconess Medical Center
In plain English

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Official title
Mind Body Intervention for Long COVID
About this study
The goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control
Eligibility 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
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-11-09
Estimated completion: 2026-12
Last updated: 2026-02-18
Interventions
Behavioral: Mind Body Intervention #1
Primary outcomes
  • Somatic Symptom Score-8 (SSS-8) (Baseline, 4 weeks, 8 weeks, 13 weeks)
Sponsor
Beth Israel Deaconess Medical Center · other
Contacts & investigators
ContactAshley Scafetta · contact · ascafett@bidmc.harvard.edu · 617-754-2882
InvestigatorMichael Donnino, MD · principal_investigator, Beth Israel Deaconess Medical Center
All locations (1)
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Mind Body Intervention for Long COVID-19 · TrialPath