The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk
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| City: |
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Durham |
| State: |
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North Carolina |
| Zip Code: |
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27705 |
| Conditions: |
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Stress, Psychological - Sleep - Inflammation - Cardiovascular Diseases |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
1. Willing to participate in an 8 week stress reduction training program
2. Between 18 and 65 years old
3. Generally in good health and not taking medication
4. Able to speak and read English
5. Willing to provide informed consent
6. Able to access the internet
7. Able to attend 4 study visits at Duke University Medical Center
Exclusion Criteria:
1. Younger than 18 years old/Older than 65
2. Asthma
3. Allergies
4. Arthritis
5. Autoimmune disease (Lupus)
6. Cancer
7. Cardiovascular disease, heart attack, or atherosclerosis
8. Diabetes or High Blood Sugar (>124 mg/dl)
9. Hypertension or high blood pressure (140/90 mmHg)
10. High cholesterol (>240 mg/dl)
11. Obesity (Body Mass Index >30)
12. Irritable Bowel Syndrome (IBS)
13. Mitral Valve Prolapse, or Heart Murmurs
14. Irregular Menstrual Cycles (Peri-Menopause Excluded. Menopause may be included.)
15. Skin conditions, such as eczema or psoriasis (acne may be included)
16. Sleep Apnea
17. Depression, anxiety, substance use, or any other mental health diagnosis
18. Sleep aids like Tylenol PM or Ambien on a regular basis
19. Medication for allergies or asthma on a regular basis
20. Aspirin or baby Aspirin on a regular basis
21. Oral contraceptives or birth control (women only)
22. Hormone Replacement Therapy
23. Flu shot within past 3 weeks
24. Underweight (BMI < 18.5)
25. Current smoker
26. >1 alcoholic drink/day (women)/ >2 alcoholic drinks/day (men)
27. Hospitalized within the last 3 months
28. Treated for any infections within the last 3 months
29. Current meditation practice >1x/month
30. Previously taken a Mindfulness-Based Stress Reduction (MBSR) course
31. Participation in any other research studies in the past year that involved drugs or
taking blood
32. Recently donated blood. (500 cc's in last 8 wks)
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| NCT ID: |
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NCT01343810 |
| Primary Contact: |
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Principal Investigator
Jeffrey M Greeson, PhD
Duke University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Durham, North Carolina 27705
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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