Back to resultsMindfulness Based Stress Reduction in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease, COPD
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction Program (MBSR)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, COPD
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MBSR
Arm Description
Outcomes
Primary Outcome Measures
We hypothesize that the perception of well being will increase after participants go through the MBSR program for COPD.
Secondary Outcome Measures
Participants in the MBSR for COPD will have an increase in their physical activity level.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01058499
Brief Title
Mindfulness Based Stress Reduction in COPD
Official Title
Mindfulness Based Stress Reduction in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD
Keywords
Chronic Obstructive Pulmonary Disease, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBSR
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction Program (MBSR)
Intervention Description
Traditional eight-week MBSR Program.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Participants in the MBSR for COPD will have an increase in their physical activity level.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Benzo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mindfulness Based Stress Reduction in COPD
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