Mindfulness Meditation in Chronic Stress

This study is currently recruiting participants.
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
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 April 15, 2014