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

NCT01343810 | Completed DMC

• 2 other identifiers: Pro000252274R00AT004945-03
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Sleep; Inflammation; Cardiovascular Diseases

Keywords

Mindfulness-Based Stress Reduction; Meditation; Psychological stress; Sleep quality; Cardiovascular disease; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (6)

• Mindfulness

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

• Health-related quality of life

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

• Negative Affect

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

• Cognitive functioning

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

• Emotion regulation

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

Study Arms (2)

Meditation

EXPERIMENTAL

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); Behavioral: Mindfulness-Based Stress Reduction (MBSR)

No meditation

ACTIVE COMPARATOR

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); Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Interventions

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.

Meditation; No meditation

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.

Meditation; No meditation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Duke Integrative Medicine

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Inflammation; Cardiovascular Diseases; Sleep Initiation and Maintenance Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jeffrey M Greeson, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 28, 2011
• Study Start: September 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 10, 2014

Record last verified: 2014-03

Locations

US (1)