Mind Body Intervention for Long COVID-19

NCT ID: NCT06045338

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2026-01-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mind Body Intervention #1

Group Type EXPERIMENTAL

Mind Body Intervention #1

Intervention Type BEHAVIORAL

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.

Mind Body Intervention #2

Group Type ACTIVE_COMPARATOR

Mind Body Intervention #1

Intervention Type BEHAVIORAL

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.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Donnino

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Donnino, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Samuel Kukler

Role: CONTACT

617-754-2882

Facility Contacts

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Samuel Kukler

Role: primary

617-754-2882

Other Identifiers

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2023P000529

Identifier Type: -

Identifier Source: org_study_id

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