Mindfulness, Emotional Well-being, and Sleep Quality

Mechanisms of Mindfulness: Effects on Sleep Quality, Stress Physiology and CVD Risk

The purpose of this study is to determine whether participating in a Mindfulness-Based Stress Reduction (MBSR) program increases mindful attention and awareness, and whether anticipated changes in mindfulness relate to improved emotional well-being, sleep quality, physical symptoms of stress, sense of spirituality, and quality of life following MBSR.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Sleep
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Detailed Description

This study will be conducted among 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 (K99 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 decreased stress-related physical symptoms, including muscle tension, headache, and gastrointestinal complaints. This study is designed to examine psychological 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): 372
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrollment in a self-pay MBSR course at Duke Integrative Medicine
• Must be able to speak and read English

Exclusion Criteria (Apply to Duke's MBSR program, and thus to the research study):

• Active substance abuse/dependence
• Severe mental illness
• Difficulty being redirected to task in a group setting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: MBSR; Participation will involve online completion of a questionnaire survey before and after the Mindfulness-Based Stress Reduction (MBSR) intervention. Specifically, research study participants will complete validated self-report measures to assess mindfulness, cognitive-emotional processes, sleep quality, symptoms of stress, sense of spirituality, and quality of life before and after the MBSR 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness	Attention to and awareness of thoughts and feelings.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Self-reported sleep quality during the past month, as indicated by sleep latency (time to fall asleep), subjective sleep quality (very good, fairly good, fairly bad, very bad), sleep duration (hours of sleep per night), sleep efficiency (# of hrs asleep/# of hrs in bed), use of sleep medication, and daytime functioning (mental clarity and energy/fatigue).	2 months
Cognitive perseveration	Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.	2 months
Emotion regulation	Strategies to regulate emotions, including suppression, reappraisal, and avoidance.	2 months
Spirituality	Ordinary experiences of connection with the transcendent in daily life.	2-months
Health-related quality of life	Mental and physical functioning and well-being during daily life.	2-months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Jeffrey M Greeson, PhD, Duke University

Publications and helpful links

General Publications

• Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862.
• Greeson JM, Webber DM, Smoski MJ, Brantley JG, Ekblad AG, Suarez EC, Wolever RQ. Changes in spirituality partly explain health-related quality of life outcomes after Mindfulness-Based Stress Reduction. J Behav Med. 2011 Dec;34(6):508-18. doi: 10.1007/s10865-011-9332-x. Epub 2011 Mar 1.

Helpful Links

• Website for the Mindfulness-Based Stress Reduction (MBSR) program at Duke Integrative Medicine
• Free full-text version of "Mindfulness Research Update:2008"

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: April 23, 2009
• First Submitted That Met QC Criteria: April 23, 2009
• First Posted (ESTIMATE): April 24, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 4, 2011
• Last Update Submitted That Met QC Criteria: October 1, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: quality of life; mindfulness; meditation; stress; spirituality; sleep quality; rumination; emotion regulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: Pro00002861; 5K99AT004945-02 (NIH)