The Benefit of Mindfulness-Based Intervention Using A Wearable Wellness Brain Sensing Device (Muse-S™) in the Treatment of Post-Covid Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in Stress
研究概览
简要总结
The purpose of this study is to assess the feasibility of using a wearable brain-sensing wellness device (Muse-S) to potentially reduce stress and anxiety during Post-Covid, which is characterized by increased stress and anxiety.
详细描述
This study will answer the following questions: 1) will patients experiencing Long-Covid Syndrome utilize a wearable brain-sensing wellness device to potentially reduce stress and anxiety 2) does using this wearable brain-sensing wellness device help decrease stress and anxiety in patients who are experiencing Long-Covid Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic Rochester.
- •Not pregnant by subject self-report at time of consent.
- •Have the ability to provide informed consent.
- •Have the ability to complete all aspects of this trial.
- •Have access to an iPhone, iPad, or Android device.
- •Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-SÔ system, as determined by the clinical investigators.
排除标准
- •Used an investigational drug within the past 30 days.
- •Anyone that is not on a stable dose of medication for anxiety, depression or sleep.
- •Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
- •Currently (within 3 weeks) has been enrolled in another clinical or research program which intervenes on the patients' QOL, or stress.
- •An unstable medical or mental health condition as determined by the physician investigator.
结局指标
主要结局
Change in Stress
时间窗: 3 months post-baseline
Stress is evaluated through the Perceived Stress Scale (PSS). This is a 10-item Likert scale that measures global life stress by assessing the degree to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The outcome measure is change in stress from baseline at 3 months (end of treatment). Negative changes indicate decreased stress relative to baseline.
Change in Anxiety
时间窗: 3 months post-baseline
PROMIS Emotional Distress-short form 7a (7 items). The PROMIS Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores were converted to t-scores using published guidelines (see PROMIS website). A T-score of 50 is the average for the general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured; thus, an increase in emotional distress T score corresponds to more anxiety - which is a worse outcome.
次要结局
未报告次要终点
研究者
Ivana T Croghan, PhD
Principal Investigator
Mayo Clinic