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

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:

MedlinePlus related topics: Stress

U.S. FDA Resources

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.

Estimated Enrollment:	200
Study Start Date:	September 2010
Estimated Study Completion Date:	June 2013
Estimated 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.

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:

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)

Contacts and Locations

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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Jeffrey M Greeson, PhD

Duke University

More Information

Additional Information:

This is a link to a description of the study on the NIH RePorter website. This link exits the ClinicalTrials.gov site

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:	January 17, 2013
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 May 19, 2013