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Completed

NCT Number: NCT01343810

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

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Cardiovascular Diseases Dyssomnias Inflammation Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Integrative Medicine

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mindfulness based stress reduction (MBSR)

Behavioral

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.

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

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 outcomes

  1. Sleep quality

    Time frame: Baseline, post-intervention (2 months), follow-up (8 months)

    Sleep quality will be assessed using 3 different methods: daily sleep diaries, questionnaires and actigraphy.

  2. Stress physiology

    Time frame: Baseline, post-intervention (2 months), follow-up (8 months)

    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 outcomes

  1. Mindfulness

    Time frame: Baseline, post-intervention (2 months), follow-up (8 months)

    Mindful qualities, including observing, describing, non-judging, non-reactivity, acting with awareness, mindfulness, self-kindness, and common humanity.

  2. Health-related quality of life

    Time frame: Baseline, post-intervention (2 months), follow-up (8 months)

    Global health rating; physical functioning; fatigue; satisfaction with social role; pain intensity and pain-related interference with daily activities.

  3. Negative Affect

    Time frame: Baseline, post-intervention (2 months), follow-up (8 months)

    Anxiety; anger; depressive symptoms.

  4. Cognitive functioning

    Time frame: Baseline, post-intervention (2 months), follow-up (8 months)

    Cognitive abilities and concerns, including attention, concentration, memory, organization, and clarity of thinking.

  5. Emotion regulation

    Time frame: Baseline, post-intervention (2 months), follow-up (8 months)

    Rumination; avoidance; suppression; reappraisal.

  6. Stress-related physical symptoms

    Time frame: Baseline, post-intervention (2 months), follow-up (8 months)

    Common physical symptoms associated with stress, including muscle tension, gastrointestinal complaints, headaches, etc.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 28, 2011
Registry last updated
Mar 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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