Mindfulness, Emotional Well-being, and Sleep Quality

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey M. Greeson, Duke University
ClinicalTrials.gov Identifier:
NCT00887614
First received: April 23, 2009
Last updated: October 1, 2011
Last verified: October 2011
  Purpose

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 Intervention
Stress, Psychological
Sleep
Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanisms of Mindfulness: Effects on Sleep Quality, Stress Physiology and CVD Risk

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Mindfulness [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Attention to and awareness of thoughts and feelings.


Secondary Outcome Measures:
  • Sleep quality [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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).

  • Cognitive perseveration [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.

  • Emotion regulation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Strategies to regulate emotions, including suppression, reappraisal, and avoidance.

  • Spirituality [ Time Frame: 2-months ] [ Designated as safety issue: No ]
    Ordinary experiences of connection with the transcendent in daily life.

  • Health-related quality of life [ Time Frame: 2-months ] [ Designated as safety issue: No ]
    Mental and physical functioning and well-being during daily life.


Enrollment: 372
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887614

Locations
United States, North Carolina
Duke Integrative Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Jeffrey M Greeson, PhD Duke University
  More Information

Additional Information:
Publications:
Responsible Party: Jeffrey M. Greeson, PhD, Duke University
ClinicalTrials.gov Identifier: NCT00887614     History of Changes
Other Study ID Numbers: Pro00002861, 5K99AT004945-02
Study First Received: April 23, 2009
Last Updated: October 1, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
mindfulness
meditation
stress
rumination
emotion regulation
sleep quality
spirituality
quality of life

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 16, 2014