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Mind Body Intervention for Long COVID-19

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Enrolling

Conditions

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

Treatments

Behavioral: Mind Body Intervention #1

Study type

Interventional

Funder types

Other

Identifiers

NCT06045338
2023P000529

Details and patient eligibility

About

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

Enrollment

180 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 3 patient groups

Mind Body Intervention #1
Experimental group
Treatment:
Behavioral: Mind Body Intervention #1
Mind Body Intervention #2
Active Comparator group
Treatment:
Behavioral: Mind Body Intervention #1
Usual Care
No Intervention group

Trial contacts and locations

1

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Central trial contact

Samuel Kukler

Data sourced from clinicaltrials.gov

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