Mind Body Intervention for Long COVID

Study Overview
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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

Official Title
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Mind Body Intervention for Long COVID

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

Intervention / Treatment
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* Behavioral: Mind Body Intervention #1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥ 18 years of age) Infection with Sars-COV2 (i. e., positive antibody, antigen, or PCR testing) Symptoms attributed only to COVID-19 and not to known comorbid disease (e.g., other infections, cancer, etc) A somatic symptom score ≥ 10 on the SSS-8 questionnaire with involvement of at least 3 domains Symptoms present at least 3 day a week for a minimum of 3 months Willingness to engage in a Mind-Body intervention Exclusion Criteria: Clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis Hospitalization in an intensive care unit for acute COVID-19 infections Age greater than 65 years Diagnosis of dementia or similar cognitive impairment Active addiction disorder (e.g. cocaine) that would interfere with study participation Major psychiatric comorbidity (e.g., schizophrenia). Mild to moderate anxiety and depression are not considered in this category

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind Body Intervention #1<br> | Behavioral: Mind Body Intervention #1<br>* 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.<br>|
| Active Comparator: Mind Body Intervention #2<br> | Behavioral: Mind Body Intervention #1<br>* 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.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Somatic Symptom Score-8 (SSS-8) | Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints | Baseline, 4 weeks, 8 weeks, 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form Brief Pain Inventory (BPI) | Used to gauge pain intensity, and pain interference with daily function over the duration of the study | Baseline, 4 weeks, 8 weeks, 13 weeks | 
| Fatigue Severity Scale (FSS) | Consists of statements relating to a patient's general level of fatigue and fatigue with specific activities | Baseline, 4 weeks, 8 weeks, 13 weeks | 
| The Multidimensional Dyspnea Profile (MDP) | A survey that assesses perceived physical aspects of dyspnea and associated emotional effects | Baseline, 4 weeks, 8 weeks, 13 weeks | 
| Generalized Anxiety Disorder form 7 (GAD-7) | Self-report instrument assessing general anxiety over the last two weeks | Baseline and 13 weeks | 
| Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS) | a standardized assessment of health-related quality of life | Baseline, 4 weeks, 8 weeks, 13 weeks | 
| End of study measurements | Participants' subjective experience of the program upon completion | 13 weeks | 
| Pain Anxiety Symptom Score-20 (Pass-20) | Anxiety from pain determined from 20 item survey | Baseline, 4 weeks, 8 weeks, 13 weeks |