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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
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.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGSomatic 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.
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Short Form Brief Pain Inventory (BPI)
Used to gauge pain intensity, and pain interference with daily function over the duration of the study
Time frame: 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. Range of 7-63, with higher scores indicating a higher degree of fatigue.
Time frame: 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.
Time frame: 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).
Time frame: Baseline and 13 weeks
Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)
a standardized assessment of health-related quality of life
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
End of study measurements
Participants' subjective experience of the program upon completion
Time frame: 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
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
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