Stress, PsychologicalNCT00887614
Mindfulness, Emotional Well-being, and Sleep Quality
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Stress, Psychological and Sleep, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Sleep
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Integrative Medicine
Durham, North Carolina, 27710
About this study
Official title: Mechanisms of Mindfulness: Effects on Sleep Quality, Stress Physiology and CVD Risk
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.
Read the 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.
- Conditions
- Stress, Psychological, Sleep
- Being tested
- Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- mindfulness, meditation, stress, rumination, emotion regulation, sleep quality, spirituality, quality of life
- Medical subject headings
- Stress, Psychological, Rumination Syndrome, Emotional Regulation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness
Attention to and awareness of thoughts and feelings.
Measured: 2 months
Secondary outcomes (5)
Sleep quality
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).
Measured: 2 months
Cognitive perseveration
Forms of distressing repetitive thought, including unwanted intrusive thoughts and rumination.
Measured: 2 months
Emotion regulation
Strategies to regulate emotions, including suppression, reappraisal, and avoidance.
Measured: 2 months
Spirituality
Ordinary experiences of connection with the transcendent in daily life.
Measured: 2-months
Health-related quality of life
Mental and physical functioning and well-being during daily life.
Measured: 2-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jeffrey M. Greeson, Duke University
- Investigators
- Jeffrey M Greeson, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887614
- Sponsor's protocol ID
- Pro00002861
- Other IDs
- 5K99AT004945-02
- Status last verified
- Oct 2011
- First submitted
- 23 Apr 2009
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862.
PubMed 20047019Greeson 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.
PubMed 21360283
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Mindfulness: Effects on Sleep Quality, Stress Physiology and CVD Risk
- ClinicalTrials.gov ID
- NCT00887614
- Acronym / sponsor ID
- Pro00002861
- Conditions
- Stress, Psychological, Sleep
- Keywords
- mindfulness, meditation, stress, rumination, emotion regulation, sleep quality, spirituality, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Enrollment in a self-pay MBSR course at Duke Integrative Medicine
- Must be able to speak and read English
- Active substance abuse/dependence
- Severe mental illness
- Difficulty being redirected to task in a group setting
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MBSR |
Primary outcome
Mindfulness
Time frame: 2 months
Attention to and awareness of thoughts and feelings.
5 secondary outcomes
Sleep quality
Time frame: 2 months
Cognitive perseveration
Time frame: 2 months
Emotion regulation
Time frame: 2 months
Spirituality
Time frame: 2-months
Health-related quality of life
Time frame: 2-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
- Background: PubMed 20047019Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862.
- Results publication: PubMed 21360283Greeson 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.
- Website for the Mindfulness-Based Stress Reduction (MBSR) program at Duke Integrative MedicineLink provided by the sponsor.
- Free full-text version of "Mindfulness Research Update:2008"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M Greeson, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Stress, Psychological and Sleep, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00887614, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.