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

NCT02467660 | Completed

• 1 other identifier: 11847
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Telephone Eligibility Screening
2. 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. 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. 4.Endpoint Visit (same as Baseline), scheduled 8 weeks after Baseline
5. 5.All participants receive Meditation and Education programs after the Endpoint Visit
6. 6.Online questionnaire follow-up 6 months after the Endpoint

Conditions

Stress, Physiological; Stress, Psychological

Outcome Measures

Primary Outcomes (3)

• Golden Stroop Cognitive Task Total Score

  Measures selective attention, cognitive flexibility, and processing speed

  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

  Change from Baseline in Heart Rate Variability at 8 weeks

• Composite multi-domain physiologic measure

  ECG, EEG, Respiration, self-report questionnaires

  Change in multiple measures from Baseline at 8 weeks

Secondary Outcomes (6)

• Rey Auditory Verbal Learning Task Total Score

  Change from Baseline in AVLT scores at 8 weeks

• Verbal Fluency Total Score

  Change from Baseline in Verbal Fluency score at 8 weeks

• Letter Number Sequencing Total Score

  Change from Baseline in Letter Number Sequencing score at 8 weeks

• Systolic and Diastolic Blood Pressure

  Change from Baseline in Systolic and Diastolic Blood Pressure at 8 weeks

• Respiration Rate

  Change from Baseline in Respiration Rate at 8 weeks

Study Arms (3)

Online Mindfulness Meditation Training

EXPERIMENTAL

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

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

Behavioral: Health & Wellness Education

Wait List Control

NO INTERVENTION

No training

Interventions

Mindfulness Meditation BEHAVIORAL

Using study-provided iPod device to listen to guided meditations daily

Online Mindfulness Meditation Training

Health & Wellness Education BEHAVIORAL

Using study-provided iPod device to listen to educational podcasts daily

Online Health & Wellness Education

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Hatfield Research Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness; Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Population Characteristics

Study Officials

• Barry S Oken, MD, MS

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 10, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

US (1)