Mind Body Intervention for Long COVID-19

Purpose

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

Conditions

  • Long COVID
  • Post-Acute Sequelae of COVID-19
  • COVID Long-Haul

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mind Body Intervention #1
  • Behavioral: Mind Body Intervention #1
    The mind-body intervention will include regular 1 to 2 hour educational sessions and lectures, as well as supplemental reading material. In addition, individualized sessions will be offered each week for students who have additional questions and/or need additional time with the material.
Active Comparator
Mind Body Intervention #2
  • Behavioral: Mind Body Intervention #1
    The mind-body intervention will include regular 1 to 2 hour educational sessions and lectures, as well as supplemental reading material. In addition, individualized sessions will be offered each week for students who have additional questions and/or need additional time with the material.
No Intervention
Usual Care

Recruiting Locations

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02115
Contact:
Samuel Kukler
617-754-2882
skukler@bidmc.harvard.edu

More Details

NCT ID
NCT06045338
Status
Recruiting
Sponsor
Beth Israel Deaconess Medical Center

Study Contact

Samuel Kukler
617-754-2882
skukler@bidmc.harvard.edu