Mindfulness Meditation in Chronic Stress

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 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: April 7, 2014
Last verified: July 2013
  Purpose

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


Condition Intervention
Chronic Stress and 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, blood, waist-to-hip ratio, weight, and electrodermal response.

  • 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

  • Changes in Physiological Markers of Stress [ Time Frame: Visit 2 (Week 8) and Endpoint (Week 16) ] [ Designated as safety issue: No ]
    Measure changes in blood pressure, heart rate, heart rate variability, neurological reaction time to visual stimuli, urine, saliva, blood, waist-to-hip ratio, weight, and electrodermal response.

  • Cognitive Changes [ Time Frame: Visit 2 (Week 8) and Endpoint (Week 16) ] [ Designated as safety issue: No ]
    In-lab cognitive tests measure attention and memory.

  • Changes in self-reported measures of stress [ Time Frame: Visit 2 (Week 8) and Endpoint (Week 16) ] [ 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
Active Comparator: Meditation Training Week 2-7
Participants receive meditation training between the 1st and 2nd study visits.
Other: Mindfulness Meditation Training
One-on-one mindfulness meditation training, 6 weeks, 1-hour training once per week, 20-min at-home practice per day.
Active Comparator: Mindfulness Meditation Week 9-15
Participants receive meditation training between the 2nd and 3rd study visits.
Other: Mindfulness Meditation Training
One-on-one mindfulness meditation training, 6 weeks, 1-hour training once per week, 20-min at-home practice per day.

  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: Meghan Miller, BA (503) 494-5650 millerme@ohsu.edu
Contact: Elena L Goodrich, BA (503) 494-7399 goodrice@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: April 7, 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 October 19, 2014