Long COVID Clinical Trial
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
Verified date | June 2024 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Health | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
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* Note: There are 39 references in all — Click here to view all references
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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