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Completed

NCT Number: NCT00887614

Mindfulness, Emotional Well-being, and Sleep Quality

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Digestive System Diseases Dyssomnias Emotional Regulation Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Nervous System Diseases Rumination Syndrome Self-Control Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Integrative Medicine

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

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 outcomes

  1. Mindfulness

    Time frame: 2 months

    Attention to and awareness of thoughts and feelings.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 24, 2009
Registry last updated
Oct 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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