Mindfulness, Emotional Well-being, and Sleep Quality

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887614
• Other study ID #: Pro00002861
• Secondary ID: 5K99AT004945-02
• Status: Completed
• Phase: N/A
• First received: April 23, 2009
• Last updated: October 1, 2011
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: October 2011
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep
• Stress, Psychological

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.

Locations

Country	Name	City	State
United States	Duke Integrative Medicine	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/s108 — View Citation

Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mindfulness	Attention to and awareness of thoughts and feelings.	2 months	No
Secondary	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).	2 months	No
Secondary	Cognitive perseveration	Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.	2 months	No
Secondary	Emotion regulation	Strategies to regulate emotions, including suppression, reappraisal, and avoidance.	2 months	No
Secondary	Spirituality	Ordinary experiences of connection with the transcendent in daily life.	2-months	No
Secondary	Health-related quality of life	Mental and physical functioning and well-being during daily life.	2-months	No

External Links

•   Free full-text version of "Mindfulness Research Update:2008"