Mindfulness, Emotional Well-being, and Sleep Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00887614
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : October 4, 2011
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jeffrey M. Greeson, Duke University

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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Sleep Behavioral: Mindfulness-Based Stress Reduction (MBSR) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 372 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms of Mindfulness: Effects on Sleep Quality, Stress Physiology and CVD Risk
Study Start Date : July 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Mindfulness [ Time Frame: 2 months ]
    Attention to and awareness of thoughts and feelings.

Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 2 months ]
    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. Cognitive perseveration [ Time Frame: 2 months ]
    Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.

  3. Emotion regulation [ Time Frame: 2 months ]
    Strategies to regulate emotions, including suppression, reappraisal, and avoidance.

  4. Spirituality [ Time Frame: 2-months ]
    Ordinary experiences of connection with the transcendent in daily life.

  5. Health-related quality of life [ Time Frame: 2-months ]
    Mental and physical functioning and well-being during daily life.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00887614

United States, North Carolina
Duke Integrative Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Jeffrey M Greeson, PhD Duke University

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Jeffrey M. Greeson, PhD, Duke University Identifier: NCT00887614     History of Changes
Other Study ID Numbers: Pro00002861
5K99AT004945-02 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: October 2011

Keywords provided by Jeffrey M. Greeson, Duke University:
emotion regulation
sleep quality
quality of life

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms