RECRUITING

Mind Body Intervention for Long COVID-19

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Mind Body Intervention for Long COVID

Quick Facts

Study Start:2023-11-09

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06045338

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Samuel Kukler

CONTACT

617-754-2882

skukler@bidmc.harvard.edu

Principal Investigator

Michael Donnino, MD

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Michael Donnino, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-09

Study Completion Date2026-01

Study Record Updates

Study Start Date2023-11-09

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

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