Clinical trial NCT01343810: Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers
Official title: The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Sleep
Inflammation
Cardiovascular Diseases
Keywords: Mindfulness-Based Stress Reduction
Meditation
Psychological stress
Sleep quality
Cardiovascular disease
Inflammation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2011-04-28
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Sleep quality
timeFrame: Baseline, post-intervention (2 months), follow-up (8 months)
measure: Stress physiology
timeFrame: Baseline, post-intervention (2 months), follow-up (8 months)
Secondary outcomes:
measure: Mindfulness
timeFrame: Baseline, post-intervention (2 months), follow-up (8 months)
measure: Health-related quality of life
timeFrame: Baseline, post-intervention (2 months), follow-up (8 months)
measure: Negative Affect
timeFrame: Baseline, post-intervention (2 months), follow-up (8 months)
measure: Cognitive functioning
timeFrame: Baseline, post-intervention (2 months), follow-up (8 months)
measure: Emotion regulation
timeFrame: Baseline, post-intervention (2 months), follow-up (8 months)
measure: Stress-related physical symptoms
timeFrame: Baseline, post-intervention (2 months), follow-up (8 months)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Integrative Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Jeffrey M Greeson, PhD
role: PRINCIPAL_INVESTIGATOR
References: