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

Primary Purpose

Stress, Psychological, Sleep, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction (MBSR)
Mindfulness-Based Stress Reduction (MBSR)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring Mindfulness-Based Stress Reduction, Meditation, Psychological stress, Sleep quality, Cardiovascular disease, Inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Duke Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Meditation

No meditation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sleep quality
Sleep quality will be assessed using 3 different methods: daily sleep diaries, questionnaires and actigraphy.
Stress physiology
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
Mindful qualities, including observing, describing, non-judging, non-reactivity, acting with awareness, mindfulness, self-kindness, and common humanity.
Health-related quality of life
Global health rating; physical functioning; fatigue; satisfaction with social role; pain intensity and pain-related interference with daily activities.
Negative Affect
Anxiety; anger; depressive symptoms.
Cognitive functioning
Cognitive abilities and concerns, including attention, concentration, memory, organization, and clarity of thinking.
Emotion regulation
Rumination; avoidance; suppression; reappraisal.
Stress-related physical symptoms
Common physical symptoms associated with stress, including muscle tension, gastrointestinal complaints, headaches, etc.

Full Information

First Posted
April 25, 2011
Last Updated
March 6, 2014
Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01343810
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Sleep, Inflammation, Cardiovascular Diseases
Keywords
Mindfulness-Based Stress Reduction, Meditation, Psychological stress, Sleep quality, Cardiovascular disease, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
No meditation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction (MBSR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction (MBSR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep quality
Description
Sleep quality will be assessed using 3 different methods: daily sleep diaries, questionnaires and actigraphy.
Time Frame
Baseline, post-intervention (2 months), follow-up (8 months)
Title
Stress physiology
Description
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.
Time Frame
Baseline, post-intervention (2 months), follow-up (8 months)
Secondary Outcome Measure Information:
Title
Mindfulness
Description
Mindful qualities, including observing, describing, non-judging, non-reactivity, acting with awareness, mindfulness, self-kindness, and common humanity.
Time Frame
Baseline, post-intervention (2 months), follow-up (8 months)
Title
Health-related quality of life
Description
Global health rating; physical functioning; fatigue; satisfaction with social role; pain intensity and pain-related interference with daily activities.
Time Frame
Baseline, post-intervention (2 months), follow-up (8 months)
Title
Negative Affect
Description
Anxiety; anger; depressive symptoms.
Time Frame
Baseline, post-intervention (2 months), follow-up (8 months)
Title
Cognitive functioning
Description
Cognitive abilities and concerns, including attention, concentration, memory, organization, and clarity of thinking.
Time Frame
Baseline, post-intervention (2 months), follow-up (8 months)
Title
Emotion regulation
Description
Rumination; avoidance; suppression; reappraisal.
Time Frame
Baseline, post-intervention (2 months), follow-up (8 months)
Title
Stress-related physical symptoms
Description
Common physical symptoms associated with stress, including muscle tension, gastrointestinal complaints, headaches, etc.
Time Frame
Baseline, post-intervention (2 months), follow-up (8 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Asthma Allergies Arthritis Autoimmune disease (Lupus) Cancer 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Greeson, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Integrative Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Links:
URL
http://tinyurl.com/Dr-JeffGreeson-K99R00-grant
Description
This is a link to a description of the study on the NIH RePorter website.

Learn more about this trial

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

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