Mindfulness Meditation in Chronic Stress

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

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

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Other: Mindfulness Meditation Training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Publications and helpful links

Helpful Links

• Oregon Center for Complementary and Alternative Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Stress; Mindfulness; Meditation
• Other Study ID Numbers: IRB7364