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Mindfulness Meditation in Chronic Stress

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01386060
First received: June 27, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

The study purpose is to evaluate efficacy of a mindfulness training intervention and learn about cognitive and physiological markers of stress.


Condition Intervention
Aging
Other: Mindfulness Meditation Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Meditation in Chronic Stress: Measures of Adherence, Ability & Stress

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Changes in Physiological Markers of Stress [ Time Frame: Baseline (Week 1) and Visit 2 (Week 8) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cognitive Changes [ Time Frame: Baseline (Week 1) and Visit 2 (Week 8) ] [ Designated as safety issue: No ]
    In-lab cognitive tests measure attention and memory.

  • Changes in self-reported measures of stress [ Time Frame: Baseline (Week 1) and Visit 2 (Week 8) ] [ Designated as safety issue: No ]
    A series of questionnaires measure different facets of perceived quality of life and stress


Estimated Enrollment: 250
Study Start Date: June 2011
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Meditation Training
Participants receive the 6-week meditation training intervention between the 1st and 2nd study visits.
Other: Mindfulness Meditation Training
One-on-one mindfulness meditation training, 6 weeks, 1 1/2 hour training once per week, 30-45 min at-home practice per day.
No Intervention: Waitlist Control
Participants receive no intervention between the 1st and 2nd study visits. They receive the training between the 2nd and 3rd study visits only.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 50-85
  • Good General Health
  • Experiencing Stress
  • No current meditation practice
  • English speaking

Exclusion Criteria:

  • Cognitive Impairment
  • Neurological Disease
  • Major Untreated Depression
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386060

Contacts
Contact: Dan Klee, BS (503) 494-5650 Klee@ohsu.edu
Contact: Tabatha Memmott (503) 494-5650 memmott@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Elena L Goodrich    503-494-7399    goodrice@ohsu.edu   
Principal Investigator: Barry Oken, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Barry Oken, MD Oregon Health and Science University
  More Information

Additional Information:
No publications provided

Responsible Party: Barry S. Oken, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01386060     History of Changes
Other Study ID Numbers: IRB7364
Study First Received: June 27, 2011
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Stress
Mindfulness
Meditation

ClinicalTrials.gov processed this record on November 23, 2014