Mindfulness Meditation in Chronic Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01386060
Recruitment Status : Active, not recruiting
First Posted : June 30, 2011
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University

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

Condition or disease Intervention/treatment Phase
Aging Other: Mindfulness Meditation Training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Meditation in Chronic Stress: Measures of Adherence, Ability & Stress
Study Start Date : June 2011
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Changes in Physiological Markers of Stress [ Time Frame: Baseline (Week 1) and Visit 2 (Week 8) ]
    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 :
  1. Cognitive Changes [ Time Frame: Baseline (Week 1) and Visit 2 (Week 8) ]
    In-lab cognitive tests measure attention and memory.

  2. Changes in self-reported measures of stress [ Time Frame: Baseline (Week 1) and Visit 2 (Week 8) ]
    A series of questionnaires measure different facets of perceived quality of life and stress

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01386060

United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Barry Oken, MD Oregon Health and Science University

Additional Information:
Responsible Party: Barry S. Oken, MD, Oregon Health and Science University Identifier: NCT01386060     History of Changes
Other Study ID Numbers: IRB7364
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Barry S. Oken, Oregon Health and Science University: