Long COVIDNCT05566379
Mindfulness in Post Acute Sequelae of SARS-CoV-2 Infection (PASC) Dysautonomia
A study testing Mindfulness - Mindful Awareness Practices ( MAPs) in people with Long COVID and Dysautonomia, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women only
- Conditions the study is for
- Long COVID, Dysautonomia
- What is being tested?
- Mindfulness - Mindful Awareness Practices ( MAPs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 29 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Inability to participate in the virtual intervention or complete outcomes surveys
- Current participation regular mindfulness practice
- Current enrollment in another COVID-19 related study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Mindfulness Intervention on Physical and Psychological Well-Being and Quality of Life in Patients With Post Acute Sequelae of SARS-CoV-2 Infection (PASC) Dysautonomia
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.
Read the detailed 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
- Conditions
- Long COVID, Dysautonomia
- Being tested
- Mindfulness - Mindful Awareness Practices ( MAPs)
- Keywords
- Mindfulness , Long COVID, Dysautonomia
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness - Mindful Awareness Practices ( MAPs)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | 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. Receives: Other: Mindfulness - Mindful Awareness Practices ( MAPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
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).
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Secondary outcomes (8)
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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).
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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.
Measured: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start28 Feb 2023
- Primary completion29 Jul 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey J. Hsu, University of California, Los Angeles
- Investigators
- Jeffrey J. Hsu, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566379
- Sponsor's protocol ID
- 22-001020
- Status last verified
- Jun 2024
- First submitted
- 2 Oct 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barizien N, Le Guen M, Russel S, Touche P, Huang F, Vallee A. Clinical characterization of dysautonomia in long COVID-19 patients. Sci Rep. 2021 Jul 7;11(1):14042. doi: 10.1038/s41598-021-93546-5.
PubMed 34234251Bisaccia 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.
PubMed 34821709Raj 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.
PubMed 33740207Nalbandian 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.
PubMed 33753937Sykes DL, Holdsworth L, Jawad N, Gunasekera P, Morice AH, Crooks MG. Post-COVID-19 Symptom Burden: What is Long-COVID and How Should We Manage It? Lung. 2021 Apr;199(2):113-119. doi: 10.1007/s00408-021-00423-z. Epub 2021 Feb 11.
PubMed 33569660Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
PubMed 33692530Antonova E, Schlosser K, Pandey R, Kumari V. Coping With COVID-19: Mindfulness-Based Approaches for Mitigating Mental Health Crisis. Front Psychiatry. 2021 Mar 23;12:563417. doi: 10.3389/fpsyt.2021.563417. eCollection 2021.
PubMed 33833695Blanck P, Perleth S, Heidenreich T, Kroger P, Ditzen B, Bents H, Mander J. Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis. Behav Res Ther. 2018 Mar;102:25-35. doi: 10.1016/j.brat.2017.12.002. Epub 2017 Dec 20.
PubMed 29291584Deng J, Zhou F, Hou W, Silver Z, Wong CY, Chang O, Huang E, Zuo QK. The prevalence of depression, anxiety, and sleep disturbances in COVID-19 patients: a meta-analysis. Ann N Y Acad Sci. 2021 Feb;1486(1):90-111. doi: 10.1111/nyas.14506. Epub 2020 Oct 2.
PubMed 33009668Johansson 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.
PubMed 33723532Graham EL, Clark JR, Orban ZS, Lim PH, Szymanski AL, Taylor C, DiBiase RM, Jia DT, Balabanov R, Ho SU, Batra A, Liotta EM, Koralnik IJ. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers". Ann Clin Transl Neurol. 2021 May;8(5):1073-1085. doi: 10.1002/acn3.51350. Epub 2021 Mar 30.
PubMed 33755344Johns 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.
PubMed 33675902Mazza 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.
PubMed 32738287Pascoe 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.
PubMed 28863392Pascoe 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.
PubMed 35757358
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mindfulness Intervention on Physical and Psychological Well-Being and Quality of Life in Patients With Post Acute Sequelae of SARS-CoV-2 Infection (PASC) Dysautonomia
- ClinicalTrials.gov ID
- NCT05566379
- Acronym / sponsor ID
- 22-001020
- Conditions
- Long COVID, Dysautonomia
- Keywords
- Mindfulness , Long COVID, Dysautonomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | 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. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to participate in the virtual intervention or complete outcomes surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Mindfulness Intervention |
Primary outcome
Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
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.
Change from baseline in Active Stand Test of hemodynamic symptom parameters, exercise tolerance.
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
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.
Change from baseline of Six Minute Walk in hemodynamic parameters, exercise tolerance
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)
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).
Change from baseline in mean score in Health-Related Quality of Life (QOL) SF-20
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
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.
8 secondary outcomes
Change from baseline in mean scores of PSS- Perceived Stress Scale.
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Change from baseline in mean scores of GAD7- Generalized Anxiety Disorder
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Change from baseline in mean scores of PHQ-8 - Depressive Symptoms
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Change from baseline in mean scores of IES-R - event-related distress scale
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Change from baseline in mean scores of FSI - The Fatigue Symptom Inventory.
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Change from baseline in mean scores of the ISI - The Insomnia Severity Index
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Change from baseline in mean scores of well-being from MHC-SF-The Mental Health Continuum Short Form
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Change from baseline in mean scores of CD-RISC 10 - Connor Davidson Resilience Scale.
Time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 34234251Barizien N, Le Guen M, Russel S, Touche P, Huang F, Vallee A. Clinical characterization of dysautonomia in long COVID-19 patients. Sci Rep. 2021 Jul 7;11(1):14042. doi: 10.1038/s41598-021-93546-5.
- Background: PubMed 34821709Bisaccia 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.
- Background: PubMed 33740207Raj 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.
- Background: PubMed 33753937Nalbandian 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.
- Background: PubMed 33569660Sykes DL, Holdsworth L, Jawad N, Gunasekera P, Morice AH, Crooks MG. Post-COVID-19 Symptom Burden: What is Long-COVID and How Should We Manage It? Lung. 2021 Apr;199(2):113-119. doi: 10.1007/s00408-021-00423-z. Epub 2021 Feb 11.
- Background: PubMed 33692530Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
- Background: PubMed 33833695Antonova E, Schlosser K, Pandey R, Kumari V. Coping With COVID-19: Mindfulness-Based Approaches for Mitigating Mental Health Crisis. Front Psychiatry. 2021 Mar 23;12:563417. doi: 10.3389/fpsyt.2021.563417. eCollection 2021.
- Background: PubMed 29291584Blanck P, Perleth S, Heidenreich T, Kroger P, Ditzen B, Bents H, Mander J. Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis. Behav Res Ther. 2018 Mar;102:25-35. doi: 10.1016/j.brat.2017.12.002. Epub 2017 Dec 20.
- Background: PubMed 33009668Deng J, Zhou F, Hou W, Silver Z, Wong CY, Chang O, Huang E, Zuo QK. The prevalence of depression, anxiety, and sleep disturbances in COVID-19 patients: a meta-analysis. Ann N Y Acad Sci. 2021 Feb;1486(1):90-111. doi: 10.1111/nyas.14506. Epub 2020 Oct 2.
- Background: PubMed 33723532Johansson 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.
- Background: PubMed 33755344Graham EL, Clark JR, Orban ZS, Lim PH, Szymanski AL, Taylor C, DiBiase RM, Jia DT, Balabanov R, Ho SU, Batra A, Liotta EM, Koralnik IJ. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers". Ann Clin Transl Neurol. 2021 May;8(5):1073-1085. doi: 10.1002/acn3.51350. Epub 2021 Mar 30.
- Background: PubMed 33675902Johns 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J. Hsu, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness - Mindful Awareness Practices ( MAPs) in people with Long COVID and Dysautonomia, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms (time frame: Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566379, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.