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Mind Body Intervention for Long COVID

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ClinicalTrials.gov Identifier: NCT06045338
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Study Description
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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 Intervention/treatment Phase
Long COVID Post-Acute Sequelae of COVID-19 COVID Long-Haul Behavioral: Mind Body Intervention #1 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mind Body Intervention for Long COVID
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Somatic Symptom Score-8 (SSS-8) [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks ]
    Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints


Secondary Outcome Measures :
  1. Short Form Brief Pain Inventory (BPI) [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks ]
    Used to gauge pain intensity, and pain interference with daily function over the duration of the study

  2. Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks ]
    Consists of statements relating to a patient's general level of fatigue and fatigue with specific activities

  3. The Multidimensional Dyspnea Profile (MDP) [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks ]
    A survey that assesses perceived physical aspects of dyspnea and associated emotional effects

  4. Generalized Anxiety Disorder form 7 (GAD-7) [ Time Frame: Baseline and 13 weeks ]
    Self-report instrument assessing general anxiety over the last two weeks

  5. Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS) [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks ]
    a standardized assessment of health-related quality of life

  6. End of study measurements [ Time Frame: 13 weeks ]
    Participants' subjective experience of the program upon completion

  7. Pain Anxiety Symptom Score-20 (Pass-20) [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks ]
    Anxiety from pain determined from 20 item survey


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045338


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

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Michael Donnino, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Michael Donnino, Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT06045338    
Other Study ID Numbers: 2023P000529
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Acute COVID-19 Syndrome
COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Post-Infectious Disorders
Chronic Disease
Disease Attributes
Pathologic Processes