Mind Body Intervention for Long COVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeth Israel Deaconess Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mind Body Intervention #1
BehavioralThe 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.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Mind Body Intervention #1Experimental treatment 1 intervention
Group B: Mind Body Intervention #2Active comparator 1 intervention
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov