Skip to content

Mindfulness, Emotional Well-being, and Sleep Quality

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00887614
Enrollment
372
Registered
2009-04-24
Start date
2009-07-31
Completion date
2010-06-30
Last updated
2011-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep, Stress, Psychological

Keywords

mindfulness, meditation, stress, rumination, emotion regulation, sleep quality, spirituality, quality of life

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.

Interventions

BEHAVIORALMindfulness-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.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mindfulness2 monthsAttention to and awareness of thoughts and feelings.

Secondary

MeasureTime frameDescription
Sleep quality2 monthsSelf-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).
Cognitive perseveration2 monthsForms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.
Emotion regulation2 monthsStrategies to regulate emotions, including suppression, reappraisal, and avoidance.
Spirituality2-monthsOrdinary experiences of connection with the transcendent in daily life.
Health-related quality of life2-monthsMental and physical functioning and well-being during daily life.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026