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Meditation or Health & Wellness Education Via Internet for Adults 50-80 Years Old

Primary Purpose

Stress, Physiological, Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation
Health & Wellness Education
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress, Physiological

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hatfield Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Online Mindfulness Meditation Training

Online Health & Wellness Education

Wait List Control

Arm Description

Weekly 1-hr online training and daily meditation for 30-45 min for 6 wks

6-week training entails completing weekly 1-hour online training and listening to educational podcasts for 30-45 minutes per day

No training

Outcomes

Primary Outcome Measures

Golden Stroop Cognitive Task Total Score
Measures selective attention, cognitive flexibility, and processing speed
Heart Rate Variability
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Composite multi-domain physiologic measure
ECG, EEG, Respiration, self-report questionnaires

Secondary Outcome Measures

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
Verbal Fluency Total Score
Measures executive function
Letter Number Sequencing Total Score
Measures executive function
Systolic and Diastolic Blood Pressure
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Respiration Rate
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
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

Full Information

First Posted
May 20, 2015
Last Updated
March 11, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT02467660
Brief Title
Meditation or Health & Wellness Education Via Internet for Adults 50-80 Years Old
Official Title
Meditation or Health & Wellness Education Via Internet for Adults 50-80 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Physiological, Stress, Psychological

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Mindfulness Meditation Training
Arm Type
Experimental
Arm Description
Weekly 1-hr online training and daily meditation for 30-45 min for 6 wks
Arm Title
Online Health & Wellness Education
Arm Type
Experimental
Arm Description
6-week training entails completing weekly 1-hour online training and listening to educational podcasts for 30-45 minutes per day
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
No training
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation
Intervention Description
Using study-provided iPod device to listen to guided meditations daily
Intervention Type
Behavioral
Intervention Name(s)
Health & Wellness Education
Intervention Description
Using study-provided iPod device to listen to educational podcasts daily
Primary Outcome Measure Information:
Title
Golden Stroop Cognitive Task Total Score
Description
Measures selective attention, cognitive flexibility, and processing speed
Time Frame
Change from Baseline in Stroop score at 8 weeks
Title
Heart Rate Variability
Description
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Time Frame
Change from Baseline in Heart Rate Variability at 8 weeks
Title
Composite multi-domain physiologic measure
Description
ECG, EEG, Respiration, self-report questionnaires
Time Frame
Change in multiple measures from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Rey Auditory Verbal Learning Task Total Score
Description
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
Time Frame
Change from Baseline in AVLT scores at 8 weeks
Title
Verbal Fluency Total Score
Description
Measures executive function
Time Frame
Change from Baseline in Verbal Fluency score at 8 weeks
Title
Letter Number Sequencing Total Score
Description
Measures executive function
Time Frame
Change from Baseline in Letter Number Sequencing score at 8 weeks
Title
Systolic and Diastolic Blood Pressure
Description
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Time Frame
Change from Baseline in Systolic and Diastolic Blood Pressure at 8 weeks
Title
Respiration Rate
Description
Used as a measure of resiliency to determine how quickly a participant returns to baseline following an experimental stressor
Time Frame
Change from Baseline in Respiration Rate at 8 weeks
Title
Salivary Cortisol Levels
Description
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
Time Frame
Change from Baseline in Cortisol Levels at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry S Oken, MD, MS
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hatfield Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Meditation or Health & Wellness Education Via Internet for Adults 50-80 Years Old

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