- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01343810
Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers
March 6, 2014 updated by: Jeffrey M. Greeson, Duke University
The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Integrative Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality
Time Frame: Baseline, post-intervention (2 months), follow-up (8 months)
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Sleep quality will be assessed using 3 different methods: daily sleep diaries, questionnaires and actigraphy.
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Baseline, post-intervention (2 months), follow-up (8 months)
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Stress physiology
Time Frame: Baseline, post-intervention (2 months), follow-up (8 months)
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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.
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Baseline, post-intervention (2 months), follow-up (8 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mindfulness
Time Frame: Baseline, post-intervention (2 months), follow-up (8 months)
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Mindful qualities, including observing, describing, non-judging, non-reactivity, acting with awareness, mindfulness, self-kindness, and common humanity.
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Baseline, post-intervention (2 months), follow-up (8 months)
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Health-related quality of life
Time Frame: Baseline, post-intervention (2 months), follow-up (8 months)
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Global health rating; physical functioning; fatigue; satisfaction with social role; pain intensity and pain-related interference with daily activities.
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Baseline, post-intervention (2 months), follow-up (8 months)
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Negative Affect
Time Frame: Baseline, post-intervention (2 months), follow-up (8 months)
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Anxiety; anger; depressive symptoms.
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Baseline, post-intervention (2 months), follow-up (8 months)
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Cognitive functioning
Time Frame: Baseline, post-intervention (2 months), follow-up (8 months)
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Cognitive abilities and concerns, including attention, concentration, memory, organization, and clarity of thinking.
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Baseline, post-intervention (2 months), follow-up (8 months)
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Emotion regulation
Time Frame: Baseline, post-intervention (2 months), follow-up (8 months)
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Rumination; avoidance; suppression; reappraisal.
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Baseline, post-intervention (2 months), follow-up (8 months)
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Stress-related physical symptoms
Time Frame: Baseline, post-intervention (2 months), follow-up (8 months)
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Common physical symptoms associated with stress, including muscle tension, gastrointestinal complaints, headaches, etc.
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Baseline, post-intervention (2 months), follow-up (8 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey M Greeson, PhD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
April 25, 2011
First Submitted That Met QC Criteria
April 27, 2011
First Posted (ESTIMATE)
April 28, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 10, 2014
Last Update Submitted That Met QC Criteria
March 6, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00025227
- 4R00AT004945-03 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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