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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05566379
Other study ID # 22-001020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 2023
Est. completion date July 29, 2023

Study information

Verified date June 2024
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current pilot study will recruit participants experiencing new, returning, or ongoing symptoms related to COVID-19 illness for at least four weeks after being first infected with SARS-CoV-2. All participants will attend a virtual 6-week course entitled Mindful Awareness Practices (MAPs) created, hosted and led by expert facilitators from the Mindful Awareness Research Center (MARC) at University of California Los Angeles (UCLA). This intervention will consist of a mix of lecture, practice, group feedback, and discussion regarding mindfulness. Mindfulness is the mental state achieved by focusing one's awareness on the present while acknowledging and accepting any feelings, thoughts, or bodily sensations. The research team will collect self-reported measures of mental health symptoms, physical health symptoms, and demographic information before and after participants attend MAPs. Objective health measures will also be collected by the research team including an active stand test, a 6-minute walk, and a blood sample.


Description:

The purpose of the current pilot project is to assess the feasibility and effects of a 6-week group mindfulness intervention in patients with Post Acute Sequelae of SARS-CoV-2 Infection (PASC)-related dysautonomia. This single-arm study uses a one group pretest/posttest design. A convenience sample of patients will be recruited from the Ahmanson-University of California Los Angeles (UCLA) COVID-19 Cardiology Specialty Clinic and UCLA Long COVID Program. Outcomes Measures: Once consented, eligible participants will complete a baseline demographics survey, preintervention assessments including the composite autonomic symptom scoring (COMPASS-31), outcome measures questionnaires for perceived stress, anxiety, depression, fatigue, resilience, sleep, event specific distress, well-being and quality of life. A peripheral blood collection device for evaluation of inflammatory gene expression will be performed along with an active stand test and 6- minute walk prior to the mindfulness intervention. The same measures will be collected following completion of the intervention. Additionally, a logbook of patient self-reported practice frequency will be reviewed, and a focused 3 question audio recorded interview will be conducted at the post intervention visit. At 4-week follow-up post intervention, the final set of assessment questionnaires, and a 3-question mindfulness experience survey will be collected. Intervention: Participants will complete a virtual group based 6-week mindfulness meditation-based intervention, Mindful Awareness Practices (MAPs), developed by Diana Winston and colleagues at the Mindful Awareness Research Center (MARC) at UCLA. In response to COVID-19 precautions participants will meet virtually for six weekly, 2-hour group sessions. The group size is estimated at 15 participants. MAPs is a standardized intervention that has been used in several previous studies. MAPS includes presentation of theoretical framework and materials on mindfulness, relaxation, and the mind-body connection, and experiential practice of meditation. Lecture, discussion, and group process focus on solving problems concerning barriers to effective practice, working with difficult thoughts and emotions, managing pain, and cultivation of loving kindness. Written materials are provided with a summary of information covered each week. Additionally, participants are instructed to practice mindfulness exercises at home on a daily basis (5-20 minutes/day) and advised in the informal use of mindfulness in daily life. Participants will be asked to keep a self-reported log of their daily practice. Classes will be led by experienced mindfulness instructors who received specialized training at the UCLA MARC Center. Overview: Baseline Visit (in person): collect within 1-2 week(s) prior to the intervention. Consent Baseline demographics survey COMPASS-31: the composite autonomic symptom score Questionnaires: perceived stress (PSS), anxiety (GAD-7), depression (PHQ 8), event specific distress (IES-R), fatigue (FSI), sleep (ISI), well-being (MHC-SF), resilience (CD-RISC10), QOL (SF-20). Tasso device blood collection for evaluation of inflammatory gene expression. Perform an active stand test Perform 6-minute walk Post Intervention Visit (in person): collect within 1-2 weeks post intervention completion COMPASS-31: the composite autonomic symptom score Questionnaires: perceived stress (PSS), anxiety (GAD-7), depression (PHQ 8), event specific distress (IES-R), fatigue (FSI), sleep (ISI), well-being (MHC-SF), resilience (CD-RISC10), QOL (SF-20). Tasso device blood collection for evaluation of inflammatory gene expression Perform an active stand test Perform Six-minute walk Three question mindfulness experience focused interview Frequency of Practice Logbook review 4-Week Post Intervention Visit (remote link / in person NOT required): collect 4 weeks (+2) post intervention Questionnaires: perceived stress (PSS), anxiety (GAD-7), depression (PHQ 8), event specific distress (IES-R), fatigue (FSI), sleep (ISI), well-being (MHC-SF), resilience (CD-RISC10), QOL (SF-20). 3-question Likert mindfulness experience survey


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 29, 2023
Est. primary completion date July 29, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 54 Years
Eligibility Inclusion Criteria: Adult females (18 years - 54 years of age) - Previous SARS-CoV-2 infection confirmed by Polymerase chain reaction (PCR) testing and diagnoses of PASC and dysautonomia confirmed by objective testing (e.g., autonomic reflex screen, active stand test) - Ability to comprehend English and complete assessments and patient-reported surveys - Availability of a smartphone, tablet, or computer with Internet access Exclusion Criteria: - Inability to participate in the virtual intervention or complete outcomes surveys - Current participation regular mindfulness practice - Current enrollment in another COVID-19 related study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mindfulness - Mindful Awareness Practices ( MAPs)
All participants will attend a virtual 6-week course entitled Mindful Awareness Practices (MAPs) created, hosted and led by expert facilitators from the Mindful Awareness Research Center at UCLA. Participants will learn Mindful concepts and a variety of Mindfulness practices. This intervention will consist of a mix of lecture, practice, group feedback, and discussion regarding mindfulness. Mindfulness is the mental state achieved by focusing one's awareness on the present while acknowledging and accepting any feelings, thoughts, or bodily sensations. MAPs classes meets weekly for two hours per week for six weeks. Participants are encouraged to complete some daily meditation practice starting at five minutes a day and working up to 20 minutes daily by the end of the course.

Locations

Country Name City State
United States UCLA Health Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (39)

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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. — View Citation

Keyes CL, Wissing M, Potgieter JP, Temane M, Kruger A, van Rooy S. Evaluation of the mental health continuum-short form (MHC-SF) in setswana-speaking South Africans. Clin Psychol Psychother. 2008 May-Jun;15(3):181-92. doi: 10.1002/cpp.572. — View Citation

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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. 2024 Feb;33(2):e5557. doi: 10.1002/pon.5557. Epub 2020 Oct 5. — View Citation

Levine GN, Lange RA, Bairey-Merz CN, Davidson RJ, Jamerson K, Mehta PK, Michos ED, Norris K, Ray IB, Saban KL, Shah T, Stein R, Smith SC Jr; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Council on Hypertension. Meditation and Cardiovascular Risk Reduction: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2017 Sep 28;6(10):e002218. doi: 10.1161/JAHA.117.002218. — View Citation

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. — View Citation

Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22. — View Citation

O'Donnell KT, Dunbar M, Speelman DL. Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Dec 9;21(1):1006. doi: 10.1186/s13063-020-04935-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Scott-Sheldon LAJ, Gathright EC, Donahue ML, Balletto B, Feulner MM, DeCosta J, Cruess DG, Wing RR, Carey MP, Salmoirago-Blotcher E. Mindfulness-Based Interventions for Adults with Cardiovascular Disease: A Systematic Review and Meta-Analysis. Ann Behav Med. 2020 Jan 1;54(1):67-73. doi: 10.1093/abm/kaz020. — View Citation

Shaygan M, Yazdani Z, Valibeygi A. The effect of online multimedia psychoeducational interventions on the resilience and perceived stress of hospitalized patients with COVID-19: a pilot cluster randomized parallel-controlled trial. BMC Psychiatry. 2021 Feb 11;21(1):93. doi: 10.1186/s12888-021-03085-6. — View Citation

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Tawakol A, Ishai A, Takx RA, Figueroa AL, Ali A, Kaiser Y, Truong QA, Solomon CJ, Calcagno C, Mani V, Tang CY, Mulder WJ, Murrough JW, Hoffmann U, Nahrendorf M, Shin LM, Fayad ZA, Pitman RK. Relation between resting amygdalar activity and cardiovascular events: a longitudinal and cohort study. Lancet. 2017 Feb 25;389(10071):834-845. doi: 10.1016/S0140-6736(16)31714-7. Epub 2017 Jan 12. Erratum In: Lancet. 2017 Feb 25;389(10071):804. Lancet. 2017 Feb 25;389(10071):804. — View Citation

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Zou L, Sasaki JE, Zeng N, Wang C, Sun L. A Systematic Review With Meta-Analysis of Mindful Exercises on Rehabilitative Outcomes Among Poststroke Patients. Arch Phys Med Rehabil. 2018 Nov;99(11):2355-2364. doi: 10.1016/j.apmr.2018.04.010. Epub 2018 May 5. — View Citation

* Note: There are 39 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The six domain scores sum to a total score of 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
Primary Change from baseline in Active Stand Test of hemodynamic symptom parameters, exercise tolerance. Active Stand Test. Clinically, an active stand test can be used to assess short-term neural and cardiovascular function and identify the hemodynamic correlates of patient symptoms and attributable causes of (pre-)syncope, and to detect autonomic dysfunction, variants of orthostatic hypotension, postural orthostatic tachycardia syndrome and orthostatic hypertension. During a standardized active stand test procedure, heart rate and blood pressure are measured after resting lying down, then immediately upon standing and after 2, 5 and 10 minutes. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
Primary Change from baseline of Six Minute Walk in hemodynamic parameters, exercise tolerance Six Minute Walk. The six-minute walk (6MWT) was developed in 1963 by Balke to evaluate functional capacity and endurance during physical activity. The standardized six-minute walk test (6MWT) measures the maximum distance an individual is able to walk over a total of six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a flat marked walkway. Baseline heart rate and oxygen saturation are measured then continuously monitored to identify the lowest oxygen saturation, which may occur before the end of the test. The patient's baseline and post-test perceived dyspnea and fatigue are rated using the Borg scale 0-10 (0 none- 10 maximum). Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
Primary Change from baseline in mean score in Health-Related Quality of Life (QOL) SF-20 Self-reported QOL SF-20. A 20-item questionnaire. The survey measures health across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question).
Scores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score. Raw scores are transformed to fit the 0% to 100% interval as described in the original publication (note that for question #1 on general health, an initial transformation is performed as follows: 1 = 5, 2 = 4.36, 3 = 3.43, 4 = 1.99, 5 = 1). Reversal of scoring is completed as necessary such that the highest score always represents the best possible score. The exception to this scoring pattern is the pain score, for which 0% represents the best possible score and 100% the worst possible score.
Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary Change from baseline in mean scores of PSS- Perceived Stress Scale. Perceived Stress Scale (PSS) appraises thoughts and feelings in perception of stress. It is a 10-item scale (score 0-40) with upper scores signifying increased perceived stress. While the aim is to capture stress level, the PSS is used to obtain a patients' perceptions of their own stress. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary Change from baseline in mean scores of GAD7- Generalized Anxiety Disorder Generalized Anxiety Disorder (GAD7) It is a 7-item scale (score 0-21), with acuity distinguished as mild (5-9), moderate (10-14) or severe (15-21) distress (Spitzer et al. 2006). The higher score indicates greater anxiety. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary Change from baseline in mean scores of PHQ-8 - Depressive Symptoms Depression (PHQ8) adapted from the PHQ-9, is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. A PHQ-8 score of 0 to 4 indicates no depression, of 5 to 9 indicates mild depression, of 10 to 14 indicates moderate depression, of 15 to 19 indicates moderately severe depression, and of 20 or higher indicates severe depression. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary Change from baseline in mean scores of IES-R - event-related distress scale Impact of Event Scale -Revised (IES-R). is a 22-item self-report measure that assesses subjective distress caused by traumatic events. The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which were not included in the original IES. Items correspond directly to 14 of the 17 The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of PTSD. Respondents are asked to identify a specific stressful life event and then indicate how much they were distressed or bothered during the past seven days by each "difficulty" listed. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary Change from baseline in mean scores of FSI - The Fatigue Symptom Inventory. The Fatigue Symptom Inventory (FSI) is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life in the past week. Severity is measured on point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured by the number of days (0-7) that respondents felt fatigued and the extent of each day they felt fatigued (0=none of the day; 10=the entire day). Perceived interference is measured on point scales (0=no interference; 10=extreme interference) that assess the degree to which fatigue was felt to interfere with with general level of activity, enjoyment, and mood. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary Change from baseline in mean scores of the ISI - The Insomnia Severity Index The Insomnia Severity Index (ISI) is a seven-item self-report questionnaire, which asks respondents to rate the nature and symptoms of their sleep problems. Dimensions evaluated are severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary Change from baseline in mean scores of well-being from MHC-SF-The Mental Health Continuum Short Form The Mental Health Continuum Short Form (MHC-SF) is a 14- item scale containing 3 items for emotional (hedonic) well-being, 5 items for social well-being, and 6 items for psychological well-being (eudaimonic). Each of the items can be scored between 0 and 5, with the total score on the scale can range from 0 to 70 points. Higher scores indicate a higher level of emotional wellbeing. This scale also provides a flourishing and languishing mental health indicator based on these three subscales. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary Change from baseline in mean scores of CD-RISC 10 - Connor Davidson Resilience Scale. Connor Davidson Resilience Scale (CD-RISC 10) is a 10-item scale (score 0-40) that measures components of adaptation, coping and recovery in response to stressful events, trauma, or tragedy. The higher scores reflect greater resilience. Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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