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OpenTrials
Completed

NCT Number: NCT01386060

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.

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Key information

Conditions

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness meditation training

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.

Primary outcomes

  1. Changes in Physiological Markers of Stress

    Time frame: Baseline (Week 1) and Visit 2 (Week 8)

    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.

Secondary outcomes

  1. Cognitive Changes

    Time frame: Baseline (Week 1) and Visit 2 (Week 8)

    In-lab cognitive tests measure attention and memory.

  2. Changes in self-reported measures of stress

    Time frame: Baseline (Week 1) and Visit 2 (Week 8)

    A series of questionnaires measure different facets of perceived quality of life and stress

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Jun 30, 2011
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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