Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey M. Greeson, Duke University
ClinicalTrials.gov Identifier:
NCT01343810
First received: April 25, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Stress, Psychological
Sleep
Inflammation
Cardiovascular Diseases
Behavioral: Mindfulness Based Stress Reduction (MBSR)
Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Sleep quality [ Time Frame: Baseline, post-intervention (2 months), follow-up (8 months) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mindfulness [ Time Frame: Baseline, post-intervention (2 months), follow-up (8 months) ] [ Designated as safety issue: No ]
    Mindful qualities, including observing, describing, non-judging, non-reactivity, acting with awareness, mindfulness, self-kindness, and common humanity.

  • Health-related quality of life [ Time Frame: Baseline, post-intervention (2 months), follow-up (8 months) ] [ Designated as safety issue: No ]
    Global health rating; physical functioning; fatigue; satisfaction with social role; pain intensity and pain-related interference with daily activities.

  • Negative Affect [ Time Frame: Baseline, post-intervention (2 months), follow-up (8 months) ] [ Designated as safety issue: No ]
    Anxiety; anger; depressive symptoms.

  • Cognitive functioning [ Time Frame: Baseline, post-intervention (2 months), follow-up (8 months) ] [ Designated as safety issue: No ]
    Cognitive abilities and concerns, including attention, concentration, memory, organization, and clarity of thinking.

  • Emotion regulation [ Time Frame: Baseline, post-intervention (2 months), follow-up (8 months) ] [ Designated as safety issue: No ]
    Rumination; avoidance; suppression; reappraisal.

  • Stress-related physical symptoms [ Time Frame: Baseline, post-intervention (2 months), follow-up (8 months) ] [ Designated as safety issue: No ]
    Common physical symptoms associated with stress, including muscle tension, gastrointestinal complaints, headaches, etc.


Enrollment: 87
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meditation
Both arms will undergo 8-weeks of Mindfulness-Based Stress Reduction (MBSR) training. The experimental arm will be randomly assigned to practice meditation immediately following the emotional stress task in the lab during the post-MBSR lab visit.
Behavioral: Mindfulness Based Stress Reduction (MBSR)
The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class.
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class.
Active Comparator: No meditation
Both arms will undergo 8-weeks of Mindfulness-Based Stress Reduction (MBSR) training. The active comparator arm will be randomly assigned to not practice meditation, but rather listen to a non-meditative audio track of equal length, immediately following the emotional stress task in the lab during the post-MBSR lab visit.
Behavioral: Mindfulness Based Stress Reduction (MBSR)
The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class.
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343810

Locations
United States, North Carolina
Duke Integrative Medicine
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Jeffrey M Greeson, PhD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey M. Greeson, PhD, Duke University
ClinicalTrials.gov Identifier: NCT01343810     History of Changes
Other Study ID Numbers: Pro00025227, 4R00AT004945-03
Study First Received: April 25, 2011
Last Updated: March 6, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
Mindfulness-Based Stress Reduction
Meditation
Psychological stress
Sleep quality
Cardiovascular disease
Inflammation

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Stress, Psychological
Pathologic Processes
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 01, 2014