This trial is active, not recruiting.

Condition aging
Treatment mindfulness meditation training
Sponsor Oregon Health and Science University
Start date June 2011
End date June 2015
Trial size 250 participants
Trial identifier NCT01386060, IRB7364


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Participants receive the 6-week meditation training intervention between the 1st and 2nd study visits.
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)
Participants receive no intervention between the 1st and 2nd study visits. They receive the training between the 2nd and 3rd study visits only.

Primary Outcomes

Changes in Physiological Markers of Stress
time frame: Baseline (Week 1) and Visit 2 (Week 8)

Secondary Outcomes

Cognitive Changes
time frame: Baseline (Week 1) and Visit 2 (Week 8)
Changes in self-reported measures of stress
time frame: Baseline (Week 1) and Visit 2 (Week 8)

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

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

Additional Information

Official title Mindfulness Meditation in Chronic Stress: Measures of Adherence, Ability & Stress
Principal investigator Barry Oken, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.