Stress, PsychologicalNCT01343810
Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers
A study testing Mindfulness Based Stress Reduction (MBSR) and 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 goal of this study is to better understand the potential value of reducing stress to ameliorate a cluster of biological and behavioral factors implicated in cardiovascular disease (CVD) risk. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Sleep, Inflammation
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR) and 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
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2013
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in an 8 week stress reduction training program
- Between 18 and 65 years old
- Generally in good health and not taking medication
- Able to speak and read English
- Willing to provide informed consent
- Able to access the internet
- Able to attend 4 study visits at Duke University Medical Center
Who cannot join
- Younger than 18 years old/Older than 65
- Asthma
- Allergies
- Arthritis
- Autoimmune disease (Lupus)
- Cancer
Show all 32Show fewer
- Cardiovascular disease, heart attack, or atherosclerosis
- Diabetes or High Blood Sugar (>124 mg/dl)
- Hypertension or high blood pressure (140/90 mmHg)
- High cholesterol (>240 mg/dl)
- Obesity (Body Mass Index >30)
- Irritable Bowel Syndrome (IBS)
- Mitral Valve Prolapse, or Heart Murmurs
- Irregular Menstrual Cycles (Peri-Menopause Excluded. Menopause may be included.)
- Skin conditions, such as eczema or psoriasis (acne may be included)
- Sleep Apnea
- Depression, anxiety, substance use, or any other mental health diagnosis
- Sleep aids like Tylenol PM or Ambien on a regular basis
- Medication for allergies or asthma on a regular basis
- Aspirin or baby Aspirin on a regular basis
- Oral contraceptives or birth control (women only)
- Hormone Replacement Therapy
- Flu shot within past 3 weeks
- Underweight (BMI < 18.5)
- Current smoker
- >1 alcoholic drink/day (women)/ >2 alcoholic drinks/day (men)
- Hospitalized within the last 3 months
- Treated for any infections within the last 3 months
- Current meditation practice >1x/month
- Previously taken a Mindfulness-Based Stress Reduction (MBSR) course
- Participation in any other research studies in the past year that involved drugs or taking blood
- Recently donated blood. (500 cc's in last 8 wks)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Integrative Medicine
Durham, North Carolina, 27705
About this study
Official title: The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk
The goal of this study is to better understand the potential value of reducing stress to ameliorate a cluster of biological and behavioral factors implicated in cardiovascular disease (CVD) risk. These factors include psychological distress, poor sleep quality, and exaggerated physiological responses to emotional stress. Results will be used to develop an innovative brief intervention to reduce risk for CVD by improving sleep quality, ameliorating psychological distress, and attenuating stress physiology.
Read the detailed description
This study will be conducted among 200 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 (R00 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 less exaggerated physiological responses to emotional stress, including blood pressure and inflammation. This study is designed to examine psychological and biological 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, Inflammation, Cardiovascular Diseases
- Being tested
- Mindfulness Based Stress Reduction (MBSR), Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- Mindfulness-Based Stress Reduction, Meditation, Psychological stress, Sleep quality, Cardiovascular disease, Inflammation
- Medical subject headings
- Stress, Psychological, Inflammation, Cardiovascular Diseases, 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.
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 |
|---|---|---|
| Meditation | Experimental | Both arms will undergo 8-weeks of Mindfulness-Based Stress Reduction (MBSR) training. The experimental arm will be randomly assigned to practice meditation immediately following the emotional stress task in the lab during the post-MBSR lab visit. Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR); Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
| No meditation | Active comparator | Both arms will undergo 8-weeks of Mindfulness-Based Stress Reduction (MBSR) training. The active comparator arm will be randomly assigned to not practice meditation, but rather listen to a non-meditative audio track of equal length, immediately following the emotional stress task in the lab during the post-MBSR lab visit. Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR); Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Sleep quality will be assessed using 3 different methods: daily sleep diaries, questionnaires and actigraphy.
Measured: Baseline, post-intervention (2 months), follow-up (8 months)
Stress physiology
Physiological responses to mild emotional stress (5-minute Anger Recall Task) will be assessed in the laboratory before and after participating in an 8-week Mindfulness-Based Stress Reduction (MBSR) program. During the stress testing sessions, we will take measures of heart rate, blood pressure, stress hormones, metabolism, inflammation, emotions, and mindful qualities.
Measured: Baseline, post-intervention (2 months), follow-up (8 months)
Secondary outcomes (6)
Mindfulness
Mindful qualities, including observing, describing, non-judging, non-reactivity, acting with awareness, mindfulness, self-kindness, and common humanity.
Measured: Baseline, post-intervention (2 months), follow-up (8 months)
Health-related quality of life
Global health rating; physical functioning; fatigue; satisfaction with social role; pain intensity and pain-related interference with daily activities.
Measured: Baseline, post-intervention (2 months), follow-up (8 months)
Negative Affect
Anxiety; anger; depressive symptoms.
Measured: Baseline, post-intervention (2 months), follow-up (8 months)
Cognitive functioning
Cognitive abilities and concerns, including attention, concentration, memory, organization, and clarity of thinking.
Measured: Baseline, post-intervention (2 months), follow-up (8 months)
Emotion regulation
Rumination; avoidance; suppression; reappraisal.
Measured: Baseline, post-intervention (2 months), follow-up (8 months)
Stress-related physical symptoms
Common physical symptoms associated with stress, including muscle tension, gastrointestinal complaints, headaches, etc.
Measured: Baseline, post-intervention (2 months), follow-up (8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 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
- NCT01343810
- Sponsor's protocol ID
- Pro00025227
- Other IDs
- 4R00AT004945-03
- Status last verified
- Mar 2014
- First submitted
- 25 Apr 2011
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk
- ClinicalTrials.gov ID
- NCT01343810
- Acronym / sponsor ID
- Pro00025227
- Conditions
- Stress, Psychological, Sleep, Inflammation, Cardiovascular Diseases
- Keywords
- Mindfulness-Based Stress Reduction, Meditation, Psychological stress, Sleep quality, Cardiovascular disease, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Apr 2011 (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 goal of this study is to better understand the potential value of reducing stress to ameliorate a cluster of biological and behavioral factors implicated in cardiovascular disease (CVD) risk. These factors include psychological distress, poor sleep quality, and exaggerated physiological responses to emotional stress. Results will be used to develop an innovative brief intervention to reduce risk for CVD by improving sleep quality, ameliorating psychological distress, and attenuating stress physiology.
Detailed description
This study will be conducted among 200 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 (R00 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 less exaggerated physiological responses to emotional stress, including blood pressure and inflammation. This study is designed to examine psychological and biological 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Behavioral: Mindfulness Based Stress Reduction (MBSR), Behavioral: Mindfulness-Based Stress Reduction (MBSR)Both arms will undergo 8-weeks of Mindfulness-Based Stress Reduction (MBSR) training. The experimental arm will be randomly assigned to practice meditation immediately following the emotional stress task in the lab during the post-MBSR lab visit. |
| No meditation | Active comparator | Behavioral: Mindfulness Based Stress Reduction (MBSR), Behavioral: Mindfulness-Based Stress Reduction (MBSR)Both arms will undergo 8-weeks of Mindfulness-Based Stress Reduction (MBSR) training. The active comparator arm will be randomly assigned to not practice meditation, but rather listen to a non-meditative audio track of equal length, immediately following the emotional stress task in the lab during the post-MBSR lab visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to participate in an 8 week stress reduction training program
- Between 18 and 65 years old
- Generally in good health and not taking medication
- Able to speak and read English
- Willing to provide informed consent
Key exclusion criteria (32 listed)
- Younger than 18 years old/Older than 65
- Asthma
- Allergies
- Arthritis
- Autoimmune disease (Lupus)
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 | Meditation, No meditation |
| 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 | Meditation, No meditation |
Primary outcome
Sleep quality
Time frame: Baseline, post-intervention (2 months), follow-up (8 months)
Sleep quality will be assessed using 3 different methods: daily sleep diaries, questionnaires and actigraphy.
Stress physiology
Time frame: Baseline, post-intervention (2 months), follow-up (8 months)
Physiological responses to mild emotional stress (5-minute Anger Recall Task) will be assessed in the laboratory before and after participating in an 8-week Mindfulness-Based Stress Reduction (MBSR) program. During the stress testing sessions, we will take measures of heart rate, blood pressure, stress hormones, metabolism, inflammation, emotions, and mindful qualities.
6 secondary outcomes
Mindfulness
Time frame: Baseline, post-intervention (2 months), follow-up (8 months)
Health-related quality of life
Time frame: Baseline, post-intervention (2 months), follow-up (8 months)
Negative Affect
Time frame: Baseline, post-intervention (2 months), follow-up (8 months)
Cognitive functioning
Time frame: Baseline, post-intervention (2 months), follow-up (8 months)
Emotion regulation
Time frame: Baseline, post-intervention (2 months), follow-up (8 months)
Stress-related physical symptoms
Time frame: Baseline, post-intervention (2 months), follow-up (8 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 10 Mar 2014.
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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) and 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 7 inclusion and 32 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 10 Mar 2014. 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?
Sleep quality (time frame: Baseline, post-intervention (2 months), follow-up (8 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2014.