Clinical trial NCT00887614: Mindfulness, Emotional Well-being, and Sleep Quality
Official title: Mechanisms of Mindfulness: Effects on Sleep Quality, Stress Physiology and CVD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Sleep
Keywords: mindfulness
meditation
stress
rumination
emotion regulation
sleep quality
spirituality
quality of life
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-04-24
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mindfulness
timeFrame: 2 months
Secondary outcomes:
measure: Sleep quality
timeFrame: 2 months
measure: Cognitive perseveration
timeFrame: 2 months
measure: Emotion regulation
timeFrame: 2 months
measure: Spirituality
timeFrame: 2-months
measure: Health-related quality of life
timeFrame: 2-months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Integrative Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Jeffrey M Greeson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862.
citation: 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.