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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343810
• Other study ID #: Pro00025227
• Secondary ID: 4R00AT004945-03
• Status: Completed
• Phase: N/A
• First received: April 25, 2011
• Last updated: March 6, 2014
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Inflammation
• Sleep
• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke Integrative Medicine	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   This is a link to a description of the study on the NIH RePorter website.