Mindfulness Based Stress Reduction in COPD

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Roberto P. Benzo, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01058499

First received: January 27, 2010

Last updated: April 18, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2010

Last Updated Date

April 18, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01058499 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Participants in the MBSR for COPD will have an increase in their physical activity level. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Mindfulness Based Stress Reduction in COPD

Official Title ^ICMJE

Mindfulness Based Stress Reduction in COPD

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease
COPD

Intervention ^ICMJE

Behavioral: Mindfulness Based Stress Reduction Program (MBSR)

Traditional eight-week MBSR Program.

Study Arm (s)

Experimental: MBSR

Intervention: Behavioral: Mindfulness Based Stress Reduction Program (MBSR)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01058499

Other Study ID Numbers ^ICMJE

09-008478

Has Data Monitoring Committee

Responsible Party

Roberto P. Benzo, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Roberto Benzo, MD

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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