Mindfulness, Emotional Well-being, and Sleep Quality
Primary Purpose
Stress, Psychological, Sleep
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction (MBSR)
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring mindfulness, meditation, stress, rumination, emotion regulation, sleep quality, spirituality, quality of life
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
Sites / Locations
- Duke Integrative Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MBSR
Arm Description
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.
Outcomes
Primary Outcome Measures
Mindfulness
Attention to and awareness of thoughts and feelings.
Secondary Outcome Measures
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).
Cognitive perseveration
Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.
Emotion regulation
Strategies to regulate emotions, including suppression, reappraisal, and avoidance.
Spirituality
Ordinary experiences of connection with the transcendent in daily life.
Health-related quality of life
Mental and physical functioning and well-being during daily life.
Full Information
NCT ID
NCT00887614
First Posted
April 23, 2009
Last Updated
October 1, 2011
Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00887614
Brief Title
Mindfulness, Emotional Well-being, and Sleep Quality
Official Title
Mechanisms of Mindfulness: Effects on Sleep Quality, Stress Physiology and CVD Risk
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Sleep
Keywords
mindfulness, meditation, stress, rumination, emotion regulation, sleep quality, spirituality, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
372 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBSR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction (MBSR)
Intervention Description
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 Measure Information:
Title
Mindfulness
Description
Attention to and awareness of thoughts and feelings.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Sleep quality
Description
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
Title
Cognitive perseveration
Description
Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.
Time Frame
2 months
Title
Emotion regulation
Description
Strategies to regulate emotions, including suppression, reappraisal, and avoidance.
Time Frame
2 months
Title
Spirituality
Description
Ordinary experiences of connection with the transcendent in daily life.
Time Frame
2-months
Title
Health-related quality of life
Description
Mental and physical functioning and well-being during daily life.
Time Frame
2-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Greeson, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Integrative Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20047019
Citation
Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862.
Results Reference
background
PubMed Identifier
21360283
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.
Results Reference
result
Links:
URL
http://www.dukeintegrativemedicine.org/index.php/2009012037/classes-workshops-events/mindfulness-based-stress-reduction.html
Description
Website for the Mindfulness-Based Stress Reduction (MBSR) program at Duke Integrative Medicine
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2679512/pdf/nihms107164.pdf
Description
Free full-text version of "Mindfulness Research Update:2008"
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Mindfulness, Emotional Well-being, and Sleep Quality
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