The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress, Psychological
- Sponsor
- Duke University
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Sleep quality
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jeffrey M. Greeson
PhD
Duke University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.)
Outcomes
Primary Outcomes
Sleep quality
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))