NCT04854772|CompletedDMC
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Sponsor study identifier
interventional
23
1 country
1
Study Start
May 15, 2021
Actual (reported)Primary Completion
August 9, 2022
Actual (reported)Study Completion
August 9, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 9, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2021
Actual (reported)April 22, 2021
Actual (reported)May 15, 2021
Actual (reported)August 9, 2022
Actual (reported)August 9, 2022
Actual (reported)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
Average Pain
Baseline, 4, 8, and 13 weeks
Pain intensity
Baseline 4, 8, and 13 weeks
Pain-related Anxiety
Baseline 4, 8, 13 weeks
Fatigue
Baseline 4, 8, 13 weeks
Dyspnea
Baseline 4, 8, and 13 weeks
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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;7(4):337-48. doi: 10.1016/j.mayocpiqo.2023.05.002. Online ahead of print.
Michael Donnino, MD
Beth Israel Deaconess Medical Center
23 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2021
First Posted
April 22, 2021
Study Start
May 15, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 9, 2022
Actual (reported)Study Completion
August 9, 2022
Actual (reported)Last Updated
August 19, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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