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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
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
COPD
 Behavioral: Mindfulness Based Stress Reduction Program (MBSR)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness Based Stress Reduction in COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBSR Behavioral: Mindfulness Based Stress Reduction Program (MBSR)
Traditional eight-week MBSR Program.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058499

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Roberto Benzo, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Roberto P. Benzo, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01058499     History of Changes
Other Study ID Numbers: 09-008478
Study First Received: January 27, 2010
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013