- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01058499
Mindfulness Based Stress Reduction in COPD
March 17, 2016 updated by: Roberto P. Benzo, Mayo Clinic
The objective of this study is to test the efficacy of a Mindfulness Based Stress Reduction program in COPD on quality of life, dyspnea, daily physical activity and mindfulness during daily life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- clinical diagnosis of COPD
- clinically significant dyspnea, as determined by a score of >=2 on the Medical Research Council of Dyspnea Score questionnaire (0-4).
Exclusion criteria:
- patients with a high likelihood of not completing the program (active chemical dependency)
- patients with an inability fo provide good data or to follow commands (neurologic or psychiatric condition).
- poor motivation or lack of interest in program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBSR
|
Traditional eight-week MBSR Program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
We hypothesize that the perception of well being will increase after participants go through the MBSR program for COPD.
Time Frame: Baseline and at eight weeks
|
Baseline and at eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participants in the MBSR for COPD will have an increase in their physical activity level.
Time Frame: Baseline and 8 weeks
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roberto Benzo, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
January 27, 2010
First Submitted That Met QC Criteria
January 27, 2010
First Posted (Estimate)
January 28, 2010
Study Record Updates
Last Update Posted (Estimate)
March 21, 2016
Last Update Submitted That Met QC Criteria
March 17, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-008478
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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