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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind Body Intervention #1 | Experimental |
| |
| Mind Body Intervention #2 | Active Comparator |
| |
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind Body Intervention #1 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Somatic Symptom Score-8 (SSS-8) | Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints. Range of 0-32, with higher scores indicating higher levels of discomfort. | Baseline, 4 weeks, 8 weeks, 13 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Scafetta | Contact | 617-754-2882 | ascafett@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Donnino, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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|
Consists of statements relating to a patient's general level of fatigue and fatigue with specific activities. Range of 7-63, with higher scores indicating a higher degree of fatigue.
| 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. Each of the rating scales within the MDP is designed to measure a separate construct, though each can be grouped between the two above mentioned domains. | 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. Each of the 7 item is a statement concerning an anxiety trait, respondents then rate how often that statement is true. Responses range from 0 (not at all) to 3 (nearly every day). | 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, with each item being scored from 1-5 in terms of frequency | Baseline, 4 weeks, 8 weeks, 13 weeks |
| Patient Reported Outcomes Measurement Information System Survey for Cognitive Function (PROMIS SF v2.0 cognitive function 8a) | Cognition assessment | Baseline, 4 weeks, 8 weeks, 13 weeks |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |