Mindfulness Meditation in Chronic Stress
The study purpose is to evaluate efficacy of a mindfulness training intervention and learn about cognitive and physiological markers of stress.
|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|
- 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.
- 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
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386060
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Barry Oken, MD||Oregon Health and Science University|