Mindfulness Meditation in Chronic Stress

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

Detailed Description
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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.

Official Title
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Mindfulness Meditation in Chronic Stress: Measures of Adherence, Ability & Stress

Conditions
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Aging

Intervention / Treatment
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* Other: Mindfulness Meditation Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation Training<br>Participants receive the 6-week meditation training intervention between the 1st and 2nd study visits. | Other: Mindfulness Meditation Training<br>* One-on-one mindfulness meditation training, 6 weeks, 1 1/2 hour training once per week, 30-45 min at-home practice per day.<br>|
| No Intervention: Waitlist Control<br>Participants receive no intervention between the 1st and 2nd study visits. They receive the training between the 2nd and 3rd study visits only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Physiological Markers of Stress | 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. | Baseline (Week 1) and Visit 2 (Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Changes | In-lab cognitive tests measure attention and memory. | Baseline (Week 1) and Visit 2 (Week 8) | 
| Changes in self-reported measures of stress | A series of questionnaires measure different facets of perceived quality of life and stress | Baseline (Week 1) and Visit 2 (Week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Mindfulness, Meditation