NCT00887614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

April 23, 2009

Last Update Submit

October 1, 2011

Conditions

Stress, PsychologicalSleep

Keywords

mindfulnessmeditationstressruminationemotion regulationsleep qualityspiritualityquality of life

Outcome Measures

Primary Outcomes (1)

  • Mindfulness

    Attention to and awareness of thoughts and feelings.

    2 months

Secondary Outcomes (5)

  • Sleep quality

    2 months

  • Cognitive perseveration

    2 months

  • Emotion regulation

    2 months

  • Spirituality

    2-months

  • Health-related quality of life

    2-months

Study Arms (1)

MBSR

EXPERIMENTAL

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)

Interventions

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.

MBSR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrollment in a self-pay MBSR course at Duke Integrative Medicine
  • Must be able to speak and read English

You may not qualify if:

  • Active substance abuse/dependence
  • Severe mental illness
  • Difficulty being redirected to task in a group setting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Integrative Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862.

    PMID: 20047019BACKGROUND

  • 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/s10865-011-9332-x. Epub 2011 Mar 1.

    PMID: 21360283RESULT

Related Links

MeSH Terms

Conditions

Stress, PsychologicalRumination SyndromeEmotional RegulationSleep Initiation and Maintenance Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersSelf-ControlSocial BehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jeffrey M Greeson, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 4, 2011

Record last verified: 2011-10

Locations

US(1)