AgingNCT01386060
Mindfulness Meditation in Chronic Stress
A study testing Mindfulness Meditation Training in people with Aging, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The study purpose is to evaluate efficacy of a mindfulness training intervention and learn about cognitive and physiological markers of stress. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Mindfulness Meditation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2017
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 50-85
- Good General Health
- Experiencing Stress
- No current meditation practice
- English speaking
Who cannot join
- Cognitive Impairment
- Neurological Disease
- Major Untreated Depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Mindfulness Meditation in Chronic Stress: Measures of Adherence, Ability & Stress
The study purpose is to evaluate efficacy of a mindfulness training intervention and learn about cognitive and physiological markers of stress.
Read the detailed description
Subjects will first undergo a phone screening, and if eligible, they will complete three study visits at Week 1, Week 8, and Week 15. The study visits involve at-home surveys, voice recordings, physical measures (height, weight, waist-to-hip ratio, and blood pressure), EEG recordings (including recordings of electrodermal activity and heart rate variability), computer tasks, in-lab saliva collection, overnight urine collection, 2-day saliva collection at bed waking, 30 minutes post-waking, afternoon, and bedtime, and a small handheld device that randomly administers eight short assessments in the subjects' natural environment. Subjects will be randomized to receive a 6-week mindfulness meditation course either between the first and second study visits or between the second and third study visits. Participants who receive training during the first and second visits will continue meditating until the third visit. The one-on-one instruction occurs once a week for 1 ½ hours, and participants are asked to listen to guided meditations and do other mindfulness-based tasks on a daily basis between sessions.
- Conditions
- Aging
- Being tested
- Mindfulness Meditation Training
- Keywords
- Stress, Mindfulness, Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation TrainingOther
One-on-one mindfulness meditation training, 6 weeks, 1 1/2 hour training once per week, 30-45 min at-home practice per day.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation Training | Experimental | Participants receive the 6-week meditation training intervention between the 1st and 2nd study visits. Receives: Other: Mindfulness Meditation Training |
| Waitlist Control | No intervention | Participants receive no intervention between the 1st and 2nd study visits. They receive the training between the 2nd and 3rd study visits only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Physiological Markers of Stress
Measure changes in blood pressure, heart rate, heart rate variability, neurological reaction time to visual stimuli, urine, saliva, waist-to-hip ratio, weight, and electrodermal response.
Measured: Baseline (Week 1) and Visit 2 (Week 8)
Secondary outcomes (2)
Cognitive Changes
In-lab cognitive tests measure attention and memory.
Measured: Baseline (Week 1) and Visit 2 (Week 8)
Changes in self-reported measures of stress
A series of questionnaires measure different facets of perceived quality of life and stress
Measured: Baseline (Week 1) and Visit 2 (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry Oken, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386060
- Sponsor's protocol ID
- IRB7364
- Status last verified
- Dec 2018
- First submitted
- 27 Jun 2011
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation in Chronic Stress: Measures of Adherence, Ability & Stress
- ClinicalTrials.gov ID
- NCT01386060
- Acronym / sponsor ID
- IRB7364
- Conditions
- Aging
- Keywords
- Stress, Mindfulness, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Jun 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 study purpose is to evaluate efficacy of a mindfulness training intervention and learn about cognitive and physiological markers of stress.
Detailed description
Subjects will first undergo a phone screening, and if eligible, they will complete three study visits at Week 1, Week 8, and Week 15. The study visits involve at-home surveys, voice recordings, physical measures (height, weight, waist-to-hip ratio, and blood pressure), EEG recordings (including recordings of electrodermal activity and heart rate variability), computer tasks, in-lab saliva collection, overnight urine collection, 2-day saliva collection at bed waking, 30 minutes post-waking, afternoon, and bedtime, and a small handheld device that randomly administers eight short assessments in the subjects' natural environment. Subjects will be randomized to receive a 6-week mindfulness meditation course either between the first and second study visits or between the second and third study visits. Participants who receive training during the first and second visits will continue meditating until the third visit. The one-on-one instruction occurs once a week for 1 ½ hours, and participants are asked to listen to guided meditations and do other mindfulness-based tasks on a daily basis between sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation Training | Experimental | Other: Mindfulness Meditation TrainingParticipants receive the 6-week meditation training intervention between the 1st and 2nd study visits. |
| Waitlist Control | No intervention | –Participants receive no intervention between the 1st and 2nd study visits. They receive the training between the 2nd and 3rd study visits only. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 50-85
- Good General Health
- Experiencing Stress
- No current meditation practice
- English speaking
Key exclusion criteria (3 listed)
- Cognitive Impairment
- Neurological Disease
- Major Untreated Depression
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 Meditation TrainingOne-on-one mindfulness meditation training, 6 weeks, 1 1/2 hour training once per week, 30-45 min at-home practice per day. | Other | Mindfulness Meditation Training |
Primary outcome
Changes in Physiological Markers of Stress
Time frame: Baseline (Week 1) and Visit 2 (Week 8)
Measure changes in blood pressure, heart rate, heart rate variability, neurological reaction time to visual stimuli, urine, saliva, waist-to-hip ratio, weight, and electrodermal response.
2 secondary outcomes
Cognitive Changes
Time frame: Baseline (Week 1) and Visit 2 (Week 8)
Changes in self-reported measures of stress
Time frame: Baseline (Week 1) and Visit 2 (Week 8)
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 19 Dec 2018.
- Oregon Center for Complementary and Alternative MedicineLink 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.
Barry Oken, MD principal investigator
Oregon Health and Science 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 Meditation Training in people with Aging, run by Oregon Health and Science 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 5 inclusion and 3 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 19 Dec 2018. 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?
Changes in Physiological Markers of Stress (time frame: Baseline (Week 1) and Visit 2 (Week 8)). 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 19 Dec 2018.