Mindfulness, Emotional Well-being, and Sleep Quality

Not Applicable

Completed

• Conditions: Stress, Psychological; Sleep
• Interventions: Behavioral: Mindfulness-Based Stress Reduction (MBSR)

• Registration Number: NCT00887614
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Study Start: 2009-07
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-01
• Last Update Posted: 2011-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBSR	Mindfulness-Based Stress Reduction (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.

Primary Outcome Measures

Name	Time	Method
Mindfulness	2 months	Attention to and awareness of thoughts and feelings.

Secondary Outcome Measures

Name	Time	Method
Spirituality	2-months	Ordinary experiences of connection with the transcendent in daily life.
Sleep quality	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).
Cognitive perseveration	2 months	Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.
Health-related quality of life	2-months	Mental and physical functioning and well-being during daily life.
Emotion regulation	2 months	Strategies to regulate emotions, including suppression, reappraisal, and avoidance.

Trial Locations

Locations (1)

Duke Integrative Medicine; 🇺🇸 Durham, North Carolina, United States