Study Summary
This trial will explore if mindfulness can help people with COVID-19 symptoms over a 6-week course.
Eligible Conditions
- Dysautonomia
- Long COVID
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 8 Secondary · Reporting Duration: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Week 2
Change from baseline in Active Stand Test of hemodynamic symptom parameters, exercise tolerance.
Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms
Change from baseline of Six Minute Walk in hemodynamic parameters, exercise tolerance
Week 4
Change from baseline in mean score in Health-Related Quality of Life (QOL) SF-20
Change from baseline in mean scores of CD-RISC 10 - Connor Davidson Resilience Scale.
Fatigue
Change from baseline in mean scores of GAD7- Generalized Anxiety Disorder
Change from baseline in mean scores of IES-R - event-related distress scale
Depressive Symptoms
Change from baseline in mean scores of PSS- Perceived Stress Scale.
Change from baseline in mean scores of the ISI - The Insomnia Severity Index
Change from baseline in mean scores of well-being from MHC-SF-The Mental Health Continuum Short Form
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Mindfulness Intervention
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Mindfulness Intervention · No Placebo Group · N/A
Mindfulness Intervention
Other
Experimental Group · 1 Intervention: Mindfulness - Mindful Awareness Practices ( MAPs) · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline / pre intervention(1-2 weeks prior to intervention), post intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,423 Previous Clinical Trials
6,773,584 Total Patients Enrolled
Jeffrey J. Hsu, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles
Eligibility Criteria
Age 18 - 54 · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- Pascoe MC, Thompson DR, Jenkins ZM, Ski CF. Mindfulness mediates the physiological markers of stress: Systematic review and meta-analysis. J Psychiatr Res. 2017 Dec;95:156-178. doi: 10.1016/j.jpsychires.2017.08.004. Epub 2017 Aug 23.
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- Johansson M, Stahlberg M, Runold M, Nygren-Bonnier M, Nilsson J, Olshansky B, Bruchfeld J, Fedorowski A. Long-Haul Post-COVID-19 Symptoms Presenting as a Variant of Postural Orthostatic Tachycardia Syndrome: The Swedish Experience. JACC Case Rep. 2021 Apr;3(4):573-580. doi: 10.1016/j.jaccas.2021.01.009. Epub 2021 Mar 10.
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- Bisaccia G, Ricci F, Recce V, Serio A, Iannetti G, Chahal AA, Stahlberg M, Khanji MY, Fedorowski A, Gallina S. Post-Acute Sequelae of COVID-19 and Cardiovascular Autonomic Dysfunction: What Do We Know? J Cardiovasc Dev Dis. 2021 Nov 15;8(11):156. doi: 10.3390/jcdd8110156.
- Raj SR, Arnold AC, Barboi A, Claydon VE, Limberg JK, Lucci VM, Numan M, Peltier A, Snapper H, Vernino S; American Autonomic Society. Long-COVID postural tachycardia syndrome: an American Autonomic Society statement. Clin Auton Res. 2021 Jun;31(3):365-368. doi: 10.1007/s10286-021-00798-2. Epub 2021 Mar 19.
- Johns SA, Tarver WL, Secinti E, Mosher CE, Stutz PV, Carnahan JL, Talib TL, Shanahan ML, Faidley MT, Kidwell KM, Rand KL. Effects of mindfulness-based interventions on fatigue in cancer survivors: A systematic review and meta-analysis of randomized controlled trials. Crit Rev Oncol Hematol. 2021 Apr;160:103290. doi: 10.1016/j.critrevonc.2021.103290. Epub 2021 Mar 4.
- Pascoe MC, de Manincor M, Tseberja J, Hallgren M, Baldwin PA, Parker AG. Psychobiological mechanisms underlying the mood benefits of meditation: A narrative review. Compr Psychoneuroendocrinol. 2021 Mar 10;6:100037. doi: 10.1016/j.cpnec.2021.100037. eCollection 2021 May.
- Simonelli C, Paneroni M, Vitacca M, Ambrosino N. Measures of physical performance in COVID-19 patients: a mapping review. Pulmonology. 2021 Nov-Dec;27(6):518-528. doi: 10.1016/j.pulmoe.2021.06.005. Epub 2021 Jun 24.
- Bower JE, Crosswell AD, Stanton AL, Crespi CM, Winston D, Arevalo J, Ma J, Cole SW, Ganz PA. Mindfulness meditation for younger breast cancer survivors: a randomized controlled trial. Cancer. 2015 Apr 15;121(8):1231-40. doi: 10.1002/cncr.29194. Epub 2014 Dec 23. Erratum In: Cancer. 2015 Jun 1;121(11):1910.
- Kubo A, Kurtovich E, McGinnis M, Aghaee S, Altschuler A, Quesenberry C Jr, Kolevska T, Liu R, Greyz-Yusupov N, Avins A. Pilot pragmatic randomized trial of mHealth mindfulness-based intervention for advanced cancer patients and their informal caregivers. Psychooncology. 2020 Sep 26. doi: 10.1002/pon.5557. Online ahead of print.
- Finucane C, van Wijnen VK, Fan CW, Soraghan C, Byrne L, Westerhof BE, Freeman R, Fedorowski A, Harms MPM, Wieling W, Kenny R. A practical guide to active stand testing and analysis using continuous beat-to-beat non-invasive blood pressure monitoring. Clin Auton Res. 2019 Aug;29(4):427-441. doi: 10.1007/s10286-019-00606-y. Epub 2019 May 10.
- Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30.
- Jeffrey J. Hsu 2023. "Mindfulness in Post Acute Sequelae of SARS-CoV-2 Infection (PASC) Dysautonomia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05566379.
Frequently Asked Questions
Is access to this medical investigation restricted to persons aged 55 and over?
"The age range of the desired participants for this trial is 18 years or older to 54 years old." - Anonymous Online Contributor
Unverified Answer
What criteria must an individual meet to be eligible for this research?
"To be eligible for this research, applicants must have dysautonomia and fall between 18-54 years of age. Approximately 30 participants are being accepted into the trial." - Anonymous Online Contributor
Unverified Answer
Is recruitment still underway for this experimental project?
"Yes, the information on clinicaltrials.gov verifies that this medical trial is currently recruiting participants. It was first posted to the website on February 1st 2023 and recently revised on January 20th 23rd. The study requires 30 individuals at a single location." - Anonymous Online Contributor
Unverified Answer
How many participants are enrolled in this trial?
"Indeed, according to clinicaltrials.gov, this medical study is soliciting participants as of now. It was initially posted on February 1st 2023 and has been recently updated on January 20th 2023. 30 individuals are sought from a single research institution." - Anonymous Online Contributor
Unverified Answer
What are the ultimate objectives of this research endeavor?
"The primary objective of the study, which will be evaluated over a pre-intervention and post-intervention timeline, is to assess changes in hemodynamic symptom parameters and exercise tolerance. Secondary outcomes include assessing Perceived Stress Scale (PSS) scores as well as Impact of Event Scale -Revised (IES-R) ratings that measure event related distress levels. Lastly, Fatigue Symptom Inventory (FSI) evaluations are used to gain insight into how fatigue affects quality of life." - Anonymous Online Contributor
Unverified Answer