COVID Long-Haul, Long COVID, Post-Acute Sequelae of COVID-19
Conditions
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
Interventions
BEHAVIORALMind 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.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Somatic Symptom Score-8 (SSS-8) | Baseline, 4 weeks, 8 weeks, 13 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form Brief Pain Inventory (BPI) | Baseline, 4 weeks, 8 weeks, 13 weeks | Used to gauge pain intensity, and pain interference with daily function over the duration of the study |
| Fatigue Severity Scale (FSS) | Baseline, 4 weeks, 8 weeks, 13 weeks | 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. |
| The Multidimensional Dyspnea Profile (MDP) | Baseline, 4 weeks, 8 weeks, 13 weeks | 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. |
| Generalized Anxiety Disorder form 7 (GAD-7) | Baseline and 13 weeks | 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). |
| Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS) | Baseline, 4 weeks, 8 weeks, 13 weeks | a standardized assessment of health-related quality of life |
| End of study measurements | 13 weeks | Participants' subjective experience of the program upon completion |
| Pain Anxiety Symptom Score-20 (Pass-20) | Baseline, 4 weeks, 8 weeks, 13 weeks | Anxiety from pain determined from 20 item survey, with each item being scored from 1-5 in terms of frequency |
| Patient Reported Outcomes Measurement Information System Survey for Cognitive Function (PROMIS SF v2.0 cognitive function 8a) | Baseline, 4 weeks, 8 weeks, 13 weeks | Cognition assessment |
Countries
United States
Contacts
CONTACTAshley Scafetta
PRINCIPAL_INVESTIGATORMichael Donnino, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed