Mind Body Intervention for COVID-19 Long Haul Syndrome

Study Overview
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Brief Summary
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The present study is a feasibility study in which we will determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome.

Detailed Description
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This study is a pilot and feasibility study to determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome in patients without evidence of ongoing tissue injury. We will perform a 12-week intervention consisting of a series of classes which will focus on knowledge therapy, desensitization, emotional expression, and stress reduction.

Official Title
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Mind Body Intervention for COVID-19 Long Haul Syndrome

Conditions
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COVID-19 Long Haul Syndrome

Intervention / Treatment
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* Behavioral: Mind Body Syndrome Therapy for Long Covid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient ≥ 18 years old New symptoms attributed to the post-covid long-haul syndrome (extremity pain, dyspnea, headaches, chest pain, fatigue) occurring after an acute phase of COVID19 Minimum of at least 12 weeks after the end of the acute phase of COVID-19 infection Persistence of symptoms for a least 1 month with no identified other organic etiology Score ≥ 3 or more on the SSS-8 score Symptoms present for a minimum of 4 days a week Willingness to consider mind-body intervention Exclusion Criteria: Patients < 18 years of age Patients > 60 years of age Diagnosed (non-COVID-19) organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments). Patients with previous severe COVID-19 disease, defined as those who had been admitted to the ICU or have objective evidence of ongoing organ injury (e.g., persistent chest radiographic abnormalities or myocarditis) Identified lung or cardiac injury in subjects with chest pain or dyspnea (e.g., chest radiograph abnormalities, cardiac ultrasound showing myocarditis or depressed ejection fraction ) Patients with a diagnosis of significant psychiatric comorbidities such as schizophrenia or dementia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility/pilot Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind Body Syndrome Therapy for Long Covid<br>The participants will receive an initial one-on-one interview, followed by 1 to 2 hour biweekly group interactive, educational sessions for 12 weeks. This program also includes a day-long retreat at the end of the required course period. Participants will also be provided reading materials to study during the intervention period | Behavioral: Mind Body Syndrome Therapy for Long Covid<br>* The intervention consists of a mind-body based intervention for the COVID long haul syndrome. The components of the intervention include knowledge therapy, desensitization, emotional expression, and stress reduction techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in somatic symptom severity | Will be assessed using the Somatic Symptom Scale-8 (SSS-8). The minimum score is 0 and the maximum 32, with higher values indicating a worse outcome (more severe symptoms) | Baseline, 4, 8, and 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain | Will be assessed using the Brief Pain Inventory (BPI). The minimum score is 0 and the maximum is 10, with higher values indicating higher pain. | Baseline, 4, 8, and 13 weeks | 
| Pain intensity | Will be assessed using the Brief Pain Inventory (BPI). The minimum score is 0 and the maximum is 10, with higher values indicating higher pain. | Baseline 4, 8, and 13 weeks | 
| Pain-related Anxiety | Will be assessed using the Pain Anxiety Symptom Scale (PASS). The minimum score is 0 and the maximum 100, with higher values indicating higher pain anxiety | Baseline 4, 8, 13 weeks | 
| Fatigue | Will be assessed using the Fatigue Severity Scale (FSS). The minimum score is 9 and the maximum 63, with higher scores indicating greater fatigue severity | Baseline 4, 8, 13 weeks | 
| Dyspnea | Will be assessed using the Multidimensional Dyspnea Profile (MDP). A1, Scale: Scale about breathing sensations with a defined start- and endpoint (neutral - unbearable). Values reach from 0-10, and higher values represent a worse outcome. SQ1 (sensoric quality), Choice: 5 Phrases and terms about breathing sensations. Choose between yes and no and select one as most accurately. SQ2 (sensoric quality), Scales: 5 subscales about intensity of breathing sensations. Values reach from 0 - 10, and higher values represent a worse outcome. A2 (emotional quality), Scales: 5 subscales about emotions. Values reach from 0 - 10, and higher values represent a worse outcome. | Baseline 4, 8, and 13 weeks | 
| Brain Fog | Will be assessed using a numerical rating scale (0-5). Higher numbers represent more severe of brain fog | Baseline, 4, 8, and 13 weeks | 
| Physical Functioning | Will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) The minimum score is 0 and maximum is 16. Higher numbers represent less physical functioning capacity. | Baseline, 4, 8, and 13 weeks. |