Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT04854772
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 4, 8, and 13 weeks
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)
Time frame: Baseline, 4, 8, and 13 weeks
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.
Time frame: Baseline 4, 8, and 13 weeks
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.
Time frame: Baseline 4, 8, 13 weeks
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
Time frame: Baseline 4, 8, 13 weeks
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
Time frame: Baseline 4, 8, and 13 weeks
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.
Time frame: Baseline, 4, 8, and 13 weeks
Will be assessed using a numerical rating scale (0-5). Higher numbers represent more severe of brain fog
Time frame: Baseline, 4, 8, and 13 weeks.
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.
Beth Israel Deaconess Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.