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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind Body Syndrome Therapy for Long Covid | Experimental | The participants will receive an initial one-on-one interview, followed by 1 to 2 hour biweekly group interactive, educational sessions for 12 weeks. This program also includes a day-long "retreat" at the end of the required course period. Participants will also be provided reading materials to study during the intervention period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind Body Syndrome Therapy for Long Covid | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in somatic symptom severity | 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) | Baseline, 4, 8, and 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain | 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. | Baseline, 4, 8, and 13 weeks |
| Pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37361483 | Derived | Donnino M, Howard P, Mehta S, Silverman J, Cabrera MJ, Yamin JB, Balaji L, Berg KM, Heydrick S, Edwards R, Grossestreuer AV. Psychophysiologic Symptom Relief Therapy (PSRT) for Post-acute Sequelae of COVID-19. Mayo Clin Proc Innov Qual Outcomes. 2023 May 19. doi: 10.1016/j.mayocpiqo.2023.05.002. Online ahead of print. |
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Feasibility/pilot Study
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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.
| Baseline 4, 8, and 13 weeks |
| Pain-related Anxiety | 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 | Baseline 4, 8, 13 weeks |
| Fatigue | 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 | Baseline 4, 8, 13 weeks |
| Dyspnea | 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. | Baseline 4, 8, and 13 weeks |
| Brain Fog | Will be assessed using a numerical rating scale (0-5). Higher numbers represent more severe of brain fog | Baseline, 4, 8, and 13 weeks |
| Physical Functioning | 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. | Baseline, 4, 8, and 13 weeks. |