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Mindfulness Meditation in Chronic Stress

NCT ID: NCT01386060

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-06-30

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.

Conditions

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Aging

Keywords

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Stress Mindfulness Meditation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness Meditation Training

Participants receive the 6-week meditation training intervention between the 1st and 2nd study visits.

Group Type EXPERIMENTAL

Mindfulness Meditation Training

Intervention Type OTHER

One-on-one mindfulness meditation training, 6 weeks, 1 1/2 hour training once per week, 30-45 min at-home practice per day.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Barry S. Oken

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry Oken, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Related Links

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http://www.ohsu.edu/orccamind

Oregon Center for Complementary and Alternative Medicine

Other Identifiers

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IRB7364

Identifier Type: -

Identifier Source: org_study_id