CClinicalTrials.gg
CompletedNCT00887614Updated Oct 4, 2011

Mindfulness, Emotional Well-being, and Sleep Quality

An interventional study of Mindfulness-Based Stress Reduction (MBSR) in Stress, Psychological and Sleep, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-04.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
372
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Stress, Psychological
  • Sleep

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Keywords

  • mindfulness
  • meditation
  • stress
  • rumination
  • emotion regulation
  • sleep quality
  • spirituality
  • quality of life
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In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

This study's enrollment of 372 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
372 participants (actual)

Study arms

  • 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)

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.

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What researchers measure

Primary outcomes

  1. Mindfulness

    Attention to and awareness of thoughts and feelings.

    Time frame: 2 months

Secondary outcomes

  1. 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).

    Time frame: 2 months

  2. Cognitive perseveration

    Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.

    Time frame: 2 months

  3. Emotion regulation

    Strategies to regulate emotions, including suppression, reappraisal, and avoidance.

    Time frame: 2 months

  4. Spirituality

    Ordinary experiences of connection with the transcendent in daily life.

    Time frame: 2-months

  5. Health-related quality of life

    Mental and physical functioning and well-being during daily life.

    Time frame: 2-months

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Study locations

1 site
  • Duke Integrative Medicine
    Durham, North Carolina 27710, United States
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References and documents

Publications

  • Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862. PubMed 20047019 ↗
  • 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. PubMed 21360283 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00887614
Lead sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Jeffrey M. Greeson (PhD, Duke University) — Principal investigator
First posted
Apr 24, 2009
Start date
Jul 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Oct 4, 2011

Study contacts

Jeffrey M Greeson, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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