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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • Hatfield Research Center

    Portland, Oregon, 97239

Other trials in United States

About this study

  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. Collect saliva samples, questionnaire data, and respond to handheld device that rings randomly for the seven days following the visit.
  3. 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
  4. Endpoint Visit (same as Baseline), scheduled 8 weeks after Baseline
  5. All participants receive Meditation and Education programs after the Endpoint Visit
  6. 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.

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 groups in NCT02467660
Study groupRoleWhat they receive
Online Mindfulness Meditation TrainingExperimentalWeekly 1-hr online training and daily meditation for 30-45 min for 6 wks
Receives: Behavioral: Mindfulness Meditation
Online Health & Wellness EducationExperimental6-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 ControlNo interventionNo training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Golden Stroop Cognitive Task Total Score

    Measures selective attention, cognitive flexibility, and processing speed

    Measured: Change from Baseline in Stroop score at 8 weeks

  2. 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

  3. Composite multi-domain physiologic measure

    ECG, EEG, Respiration, self-report questionnaires

    Measured: Change in multiple measures from Baseline at 8 weeks

Secondary outcomes (6)
  1. 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

  2. Verbal Fluency Total Score

    Measures executive function

    Measured: Change from Baseline in Verbal Fluency score at 8 weeks

  3. Letter Number Sequencing Total Score

    Measures executive function

    Measured: Change from Baseline in Letter Number Sequencing score at 8 weeks

  4. 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

  5. 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

  6. 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.

  1. First posted10 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionAug 2018
  4. Study completionJan 2019

Resources

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)
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

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.

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