Mindfulness Meditation in Chronic Stress

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386060
• Other study ID #: IRB7364
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: June 2017

Study information

• Verified date: December 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cognitive Changes	In-lab cognitive tests measure attention and memory.	Baseline (Week 1) and Visit 2 (Week 8)
Secondary	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)

External Links

•   Oregon Center for Complementary and Alternative Medicine