The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Sleep quality
研究概览
简要总结
The goal of this study is to better understand the potential value of reducing stress to ameliorate a cluster of biological and behavioral factors implicated in cardiovascular disease (CVD) risk. These factors include psychological distress, poor sleep quality, and exaggerated physiological responses to emotional stress. Results will be used to develop an innovative brief intervention to reduce risk for CVD by improving sleep quality, ameliorating psychological distress, and attenuating stress physiology.
详细描述
This study will be conducted among 200 men and women participating in 8-week Mindfulness-Based Stress Reduction (MBSR) classes at Duke Integrative Medicine in Durham, North Carolina. The central hypothesis of this NIH-funded clinical trial (R00 AT004945, PI: Greeson) is that mindfulness meditation training is associated with increased levels of mindfulness and improved cognitive-emotional functioning that, together, are associated with reduced psychological distress, improved sleep quality, and less exaggerated physiological responses to emotional stress, including blood pressure and inflammation. This study is designed to examine psychological and biological mechanisms that may explain individual differences in MBSR outcomes. This knowledge is important because it will help us better understand who is most likely to benefit from mindfulness meditation training, and why. The results from this study are expected to elucidate mechanisms underlying the mental and physical health benefits of stress reduction, which can help guide clinicians in referring the most suitable patients to local MBSR programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate in an 8 week stress reduction training program
- •Between 18 and 65 years old
- •Generally in good health and not taking medication
- •Able to speak and read English
- •Willing to provide informed consent
- •Able to access the internet
- •Able to attend 4 study visits at Duke University Medical Center
排除标准
- •Younger than 18 years old/Older than 65
- •Autoimmune disease (Lupus)
- •Cardiovascular disease, heart attack, or atherosclerosis
- •Diabetes or High Blood Sugar (>124 mg/dl)
- •Hypertension or high blood pressure (140/90 mmHg)
- •High cholesterol (>240 mg/dl)
- •Obesity (Body Mass Index >30)
- •Irritable Bowel Syndrome (IBS)
- •Mitral Valve Prolapse, or Heart Murmurs
- •Irregular Menstrual Cycles (Peri-Menopause Excluded. Menopause may be included.)
- •Skin conditions, such as eczema or psoriasis (acne may be included)
- •Sleep Apnea
- •Depression, anxiety, substance use, or any other mental health diagnosis
- •Sleep aids like Tylenol PM or Ambien on a regular basis
- •Medication for allergies or asthma on a regular basis
- •Aspirin or baby Aspirin on a regular basis
- •Oral contraceptives or birth control (women only)
- •Hormone Replacement Therapy
- •Flu shot within past 3 weeks
- •Underweight (BMI < 18.5)
- •Current smoker
- •>1 alcoholic drink/day (women)/ >2 alcoholic drinks/day (men)
- •Hospitalized within the last 3 months
- •Treated for any infections within the last 3 months
- •Current meditation practice >1x/month
- •Previously taken a Mindfulness-Based Stress Reduction (MBSR) course
- •Participation in any other research studies in the past year that involved drugs or taking blood
- •Recently donated blood. (500 cc's in last 8 wks)
结局指标
主要结局
Sleep quality
时间窗: Baseline, post-intervention (2 months), follow-up (8 months)
Sleep quality will be assessed using 3 different methods: daily sleep diaries, questionnaires and actigraphy.
Stress physiology
时间窗: Baseline, post-intervention (2 months), follow-up (8 months)
Physiological responses to mild emotional stress (5-minute Anger Recall Task) will be assessed in the laboratory before and after participating in an 8-week Mindfulness-Based Stress Reduction (MBSR) program. During the stress testing sessions, we will take measures of heart rate, blood pressure, stress hormones, metabolism, inflammation, emotions, and mindful qualities.
次要结局
- Mindfulness(Baseline, post-intervention (2 months), follow-up (8 months))
- Health-related quality of life(Baseline, post-intervention (2 months), follow-up (8 months))
- Negative Affect(Baseline, post-intervention (2 months), follow-up (8 months))
- Cognitive functioning(Baseline, post-intervention (2 months), follow-up (8 months))
- Emotion regulation(Baseline, post-intervention (2 months), follow-up (8 months))
- Stress-related physical symptoms(Baseline, post-intervention (2 months), follow-up (8 months))
研究者
Jeffrey M. Greeson
PhD
Duke University