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NCT06045338 | RECRUITING | Long COVID

Mind Body Intervention for Long COVID-19
Sponsor:

Beth Israel Deaconess Medical Center

Information provided by (Responsible Party):

Michael Donnino

Brief Summary:

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

Condition or disease

Long COVID

Post-Acute Sequelae of COVID-19

COVID Long-Haul

Intervention/treatment

Mind Body Intervention #1

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Mind Body Intervention for Long COVID
Actual Study Start Date : 2023-11-09
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2026-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Mind Body Intervention for Long COVID-19

Location Details

NCT06045338

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115