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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 54 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Inability to participate in the virtual intervention or complete outcomes surveys
- •Current participation regular mindfulness practice
- •Current enrollment in another COVID-19 related study.
结局指标
主要结局
Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change from baseline in mean scores of PHQ-8 - Depressive Symptoms(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(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 PSS- Perceived Stress Scale.(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.(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(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(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.(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(Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention)
研究者
Jeffrey J. Hsu
Principal Investigator
University of California, Los Angeles
