Stress, PhysiologicalNCT02467660
Meditation or Health & Wellness Education Via Internet for Adults 50-80 Years Old
A study testing Mindfulness Meditation and Health & Wellness Education in people with Stress, Physiological and Stress, Psychological, run by Oregon Health and Science University at 1 site in United States.
Trial summary
1. Telephone Eligibility Screening 2. Baseline Visit, includes online questionnaires, physical measures, cognitive tasks, voice recordings, physical recordings of brain waves, heart rate, breathing rate, and sweat during computer tasks. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological, Stress, Psychological
- What is being tested?
- Mindfulness Meditation and Health & Wellness Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 50 and 80 years old
- Be stable on all medications for at least 2 months and willing to NOT change medications for the duration of the study
- Have access to a computer with internet in order to complete online questionnaires three separate times and complete 1-hour trainings once per week for six weeks
- Willing to travel to OHSU for a total of three times
- Willing to follow the study protocol, including completely weekly internet-based trainings and doing 30-45 minutes of home practice daily for 6 weeks IF randomly assigned to receive the meditation or education trainings
Who cannot join
- Have any significant medical or neurological diseases, such as major organ failure, insulin-dependent diabetes, or active cancer
- Have significant untreated depression
- Have significant visual or hearing impairment
- Take certain medications in the last 2 months, such as neuroleptics or steroids
- Have prior experience with mediation classes or other mind-body classes (e.g. yoga or tai chi) within the past 2 years
- Have had a regular meditation practice in the past 30 days
- Be gone for more than one full week during study participation
Trial locations and contacts
1 site in 1 country.
About this study
- Telephone Eligibility Screening
- Baseline Visit, includes online questionnaires, physical measures, cognitive tasks, voice recordings, physical recordings of brain waves, heart rate, breathing rate, and sweat during computer tasks. Collect saliva samples, questionnaire data, and respond to handheld device that rings randomly for the seven days following the visit.
- Randomized to receive (a) an internet-based Mindfulness Meditation program, (b) an internet-based Health \& Wellness Education program, or (c) no training. IF assigned to receive a training program, participants complete weekly one-hour online trainings and daily home practice for 6 weeks
- Endpoint Visit (same as Baseline), scheduled 8 weeks after Baseline
- All participants receive Meditation and Education programs after the Endpoint Visit
- Online questionnaire follow-up 6 months after the Endpoint
Read the detailed description
The primary aim of this research project is to evaluate whether an internet-based mindfulness meditation training improves cognition and resilience in stressed older adults. Dr. Oken specializes in evaluating the effects of stress on the human body, and he plans to use advanced statistical analyses to create a "multi-domain physiologic measure." This means study staff will collect biological data, including electroencephalogram (EEG, brainwaves), blood pressure, heart rate, breathing rate, and saliva samples. The investigator hypothesizes that when he statistically combines all of these together, he will have a measure that correlates with self-rated (survey) measures of resilience and stress.
Participants will undergo a telephone screening to determine eligibility, and then they will fill out online questionnaires before their Baseline Visit at the lab. Study staff will take physical measurements (i.e. height, weight, vision), administer short cognitive tasks that measure attention and memory, and collect biological data (listed above) during several different tasks. Some of the tasks are very simple, such as breath counting and listening to an audio recording of a podcast. And some of the tasks are intended to be more stressful, such as one that presents difficult math problems. The investigator hopes to induce stress so that study staff can measure resilience by evaluating how long it takes participants to return to a biological baseline, such as their usual blood pressure. In total, the visit is approximately 3 ½ hours long.
After the Baseline, participants are sent home with a handheld device that administers random 5-minute assessments, as well as tubes to collect saliva, for the seven days following the in-lab visit. Participants will also fill out short questionnaires about daily events over these seven days. Once data collection is complete, participants will come into the lab to return the device and samples and learn whether they have been randomized to receive the internet-based mindfulness meditation training (40% chance), an internet-based health \& wellness education program (40% chance), or a non-active waitlist (20% chance). All participants will be informed before the study begins that they will have access to the meditation and education materials once their participation is complete. Participants receiving the meditation and education will complete a one-hour online training each week for six weeks, and they will use an iPod to listen to guided meditations or educational podcasts (depending on group assignment) for 30-45 minutes per day. The iPod tracks their home practice, and they will return it at the end of the study. All participants will receive a weekly call from study staff to check in about whether they have experienced any health changes and, if applicable, how the meditation or education program is going.
Eight weeks after the Baseline Visit, participants will again fill out online questionnaires and come back to the lab for an Endpoint Visit, which is very similar to the Baseline. They will again collect saliva samples and complete assessments on a handheld device for two days following the visit. They will mail the samples and device back to the lab and then receive access to both internet-based training programs and associated audio recordings. Participants will then be asked to fill out online questionnaires one last time 6 months after the Endpoint Visit.
- Conditions
- Stress, Physiological, Stress, Psychological
- Being tested
- Mindfulness Meditation, Health & Wellness Education
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
Using study-provided iPod device to listen to guided meditations daily
Health & Wellness EducationBehavioural
Using study-provided iPod device to listen to educational podcasts daily
| Study group | Role | What they receive |
|---|---|---|
| Online Mindfulness Meditation Training | Experimental | Weekly 1-hr online training and daily meditation for 30-45 min for 6 wks Receives: Behavioral: Mindfulness Meditation |
| Online Health & Wellness Education | Experimental | 6-week training entails completing weekly 1-hour online training and listening to educational podcasts for 30-45 minutes per day Receives: Behavioral: Health & Wellness Education |
| Wait List Control | No intervention | No training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Golden Stroop Cognitive Task Total Score
Measures selective attention, cognitive flexibility, and processing speed
Measured: Change from Baseline in Stroop score at 8 weeks
Heart Rate Variability
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Measured: Change from Baseline in Heart Rate Variability at 8 weeks
Composite multi-domain physiologic measure
ECG, EEG, Respiration, self-report questionnaires
Measured: Change in multiple measures from Baseline at 8 weeks
Secondary outcomes (6)
Rey Auditory Verbal Learning Task Total Score
Evaluates short-term auditory-verbal memory, rate of learning, learning strategies, retroactive and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval
Measured: Change from Baseline in AVLT scores at 8 weeks
Verbal Fluency Total Score
Measures executive function
Measured: Change from Baseline in Verbal Fluency score at 8 weeks
Letter Number Sequencing Total Score
Measures executive function
Measured: Change from Baseline in Letter Number Sequencing score at 8 weeks
Systolic and Diastolic Blood Pressure
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Measured: Change from Baseline in Systolic and Diastolic Blood Pressure at 8 weeks
Respiration Rate
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Measured: Change from Baseline in Respiration Rate at 8 weeks
Salivary Cortisol Levels
Measures general stress from baseline to endpoint and it's also used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor; Several samples are taken during Baseline and Endpoint Assessments (8 weeks apart), and four samples are collected each day for two days following the Baseline and two days following the Endpoint
Measured: Change from Baseline in Cortisol Levels at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 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 S Oken, MD, MS, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467660
- Sponsor's protocol ID
- 11847
- Status last verified
- Mar 2019
- First submitted
- 20 May 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation or Health & Wellness Education Via Internet for Adults 50-80 Years Old
- ClinicalTrials.gov ID
- NCT02467660
- Acronym / sponsor ID
- 11847
- Conditions
- Stress, Physiological, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 10 Jun 2015 (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.
- Telephone Eligibility Screening
- Baseline Visit, includes online questionnaires, physical measures, cognitive tasks, voice recordings, physical recordings of brain waves, heart rate, breathing rate, and sweat during computer tasks. Collect saliva samples, questionnaire data, and respond to handheld device that rings randomly for the seven days following the visit.
- Randomized to receive (a) an internet-based Mindfulness Meditation program, (b) an internet-based Health \& Wellness Education program, or (c) no training. IF assigned to receive a training program, participants complete weekly one-hour online trainings and daily home practice for 6 weeks
- Endpoint Visit (same as Baseline), scheduled 8 weeks after Baseline
- All participants receive Meditation and Education programs after the Endpoint Visit
- Online questionnaire follow-up 6 months after the Endpoint
Detailed description
The primary aim of this research project is to evaluate whether an internet-based mindfulness meditation training improves cognition and resilience in stressed older adults. Dr. Oken specializes in evaluating the effects of stress on the human body, and he plans to use advanced statistical analyses to create a "multi-domain physiologic measure." This means study staff will collect biological data, including electroencephalogram (EEG, brainwaves), blood pressure, heart rate, breathing rate, and saliva samples. The investigator hypothesizes that when he statistically combines all of these together, he will have a measure that correlates with self-rated (survey) measures of resilience and stress.
Participants will undergo a telephone screening to determine eligibility, and then they will fill out online questionnaires before their Baseline Visit at the lab. Study staff will take physical measurements (i.e. height, weight, vision), administer short cognitive tasks that measure attention and memory, and collect biological data (listed above) during several different tasks. Some of the tasks are very simple, such as breath counting and listening to an audio recording of a podcast. And some of the tasks are intended to be more stressful, such as one that presents difficult math problems. The investigator hopes to induce stress so that study staff can measure resilience by evaluating how long it takes participants to return to a biological baseline, such as their usual blood pressure. In total, the visit is approximately 3 ½ hours long.
After the Baseline, participants are sent home with a handheld device that administers random 5-minute assessments, as well as tubes to collect saliva, for the seven days following the in-lab visit. Participants will also fill out short questionnaires about daily events over these seven days. Once data collection is complete, participants will come into the lab to return the device and samples and learn whether they have been randomized to receive the internet-based mindfulness meditation training (40% chance), an internet-based health \& wellness education program (40% chance), or a non-active waitlist (20% chance). All participants will be informed before the study begins that they will have access to the meditation and education materials once their participation is complete. Participants receiving the meditation and education will complete a one-hour online training each week for six weeks, and they will use an iPod to listen to guided meditations or educational podcasts (depending on group assignment) for 30-45 minutes per day. The iPod tracks their home practice, and they will return it at the end of the study. All participants will receive a weekly call from study staff to check in about whether they have experienced any health changes and, if applicable, how the meditation or education program is going.
Eight weeks after the Baseline Visit, participants will again fill out online questionnaires and come back to the lab for an Endpoint Visit, which is very similar to the Baseline. They will again collect saliva samples and complete assessments on a handheld device for two days following the visit. They will mail the samples and device back to the lab and then receive access to both internet-based training programs and associated audio recordings. Participants will then be asked to fill out online questionnaires one last time 6 months after the Endpoint Visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online Mindfulness Meditation Training | Experimental | Behavioral: Mindfulness MeditationWeekly 1-hr online training and daily meditation for 30-45 min for 6 wks |
| Online Health & Wellness Education | Experimental | Behavioral: Health & Wellness Education6-week training entails completing weekly 1-hour online training and listening to educational podcasts for 30-45 minutes per day |
| Wait List Control | No intervention | –No training |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 50 and 80 years old
- Be stable on all medications for at least 2 months and willing to NOT change medications for the duration of the study
- Have access to a computer with internet in order to complete online questionnaires three separate times and complete 1-hour trainings once per week for six weeks
- Willing to travel to OHSU for a total of three times
- Willing to follow the study protocol, including completely weekly internet-based trainings and doing 30-45 minutes of home practice daily for 6 weeks IF randomly assigned to receive the meditation or education trainings
Key exclusion criteria (7 listed)
- Have any significant medical or neurological diseases, such as major organ failure, insulin-dependent diabetes, or active cancer
- Have significant untreated depression
- Have significant visual or hearing impairment
- Take certain medications in the last 2 months, such as neuroleptics or steroids
- Have prior experience with mediation classes or other mind-body classes (e.g. yoga or tai chi) within the past 2 years
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 MeditationUsing study-provided iPod device to listen to guided meditations daily | Behavioural | Online Mindfulness Meditation Training |
| Health & Wellness EducationUsing study-provided iPod device to listen to educational podcasts daily | Behavioural | Online Health & Wellness Education |
Primary outcome
Golden Stroop Cognitive Task Total Score
Time frame: Change from Baseline in Stroop score at 8 weeks
Measures selective attention, cognitive flexibility, and processing speed
Heart Rate Variability
Time frame: Change from Baseline in Heart Rate Variability at 8 weeks
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Composite multi-domain physiologic measure
Time frame: Change in multiple measures from Baseline at 8 weeks
ECG, EEG, Respiration, self-report questionnaires
6 secondary outcomes
Rey Auditory Verbal Learning Task Total Score
Time frame: Change from Baseline in AVLT scores at 8 weeks
Verbal Fluency Total Score
Time frame: Change from Baseline in Verbal Fluency score at 8 weeks
Letter Number Sequencing Total Score
Time frame: Change from Baseline in Letter Number Sequencing score at 8 weeks
Systolic and Diastolic Blood Pressure
Time frame: Change from Baseline in Systolic and Diastolic Blood Pressure at 8 weeks
Respiration Rate
Time frame: Change from Baseline in Respiration Rate at 8 weeks
Salivary Cortisol Levels
Time frame: Change from Baseline in Cortisol Levels at 8 weeks
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 13 Mar 2019.
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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 S Oken, MD, MS 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 and Health & Wellness Education in people with Stress, Physiological and Stress, Psychological, 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 7 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 13 Mar 2019. 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?
Golden Stroop Cognitive Task Total Score (time frame: Change from Baseline in Stroop score at 8 weeks). The study lists 3 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 13 Mar 2019.