NCT01386060

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

4 years

First QC Date

June 27, 2011

Last Update Submit

December 14, 2018

Conditions

Aging

Keywords

StressMindfulnessMeditation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cognitive Changes

    Baseline (Week 1) and Visit 2 (Week 8)

  • Changes in self-reported measures of stress

    Baseline (Week 1) and Visit 2 (Week 8)

Study Arms (2)

Mindfulness Meditation Training

EXPERIMENTAL

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

Other: Mindfulness Meditation Training

Waitlist Control

NO INTERVENTION

Participants receive no intervention between the 1st and 2nd study visits. They receive the training between the 2nd and 3rd study visits only.

Interventions

Mindfulness Meditation TrainingOTHER

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

Mindfulness Meditation Training

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 50-85
  • Good General Health
  • Experiencing Stress
  • No current meditation practice
  • English speaking

You may not qualify if:

  • Cognitive Impairment
  • Neurological Disease
  • Major Untreated Depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Links

Study Officials

  • Barry Oken, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 30, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2017

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations

US(1)