Mindfulness, Emotional Well-being, and Sleep Quality
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|ClinicalTrials.gov Identifier: NCT00887614|
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : October 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological Sleep||Behavioral: Mindfulness-Based Stress Reduction (MBSR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||372 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanisms of Mindfulness: Effects on Sleep Quality, Stress Physiology and CVD Risk|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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.
- Mindfulness [ Time Frame: 2 months ]Attention to and awareness of thoughts and feelings.
- 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).
- Cognitive perseveration [ Time Frame: 2 months ]Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.
- Emotion regulation [ Time Frame: 2 months ]Strategies to regulate emotions, including suppression, reappraisal, and avoidance.
- Spirituality [ Time Frame: 2-months ]Ordinary experiences of connection with the transcendent in daily life.
- Health-related quality of life [ Time Frame: 2-months ]Mental and physical functioning and well-being during daily life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887614
|United States, North Carolina|
|Duke Integrative Medicine|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Jeffrey M Greeson, PhD||Duke University|