Mindfulness, Emotional Well-being, and Sleep Quality

Duke University

Status: Completed

Conditions: Stress, Psychological; Sleep

Treatments: Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00887614

5K99AT004945-02 (U.S. NIH Grant/Contract)

Pro00002861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

372 participants in 1 patient group

MBSR

Experimental group

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction (MBSR)