NCT01058499

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2010

Typical duration for phase_1 chronic-obstructive-pulmonary-disease

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

January 27, 2010

Last Update Submit

March 17, 2016

Conditions

Chronic Obstructive Pulmonary DiseaseCOPD

Keywords

Chronic Obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (1)

  • We hypothesize that the perception of well being will increase after participants go through the MBSR program for COPD.

    Baseline and at eight weeks

Secondary Outcomes (1)

  • Participants in the MBSR for COPD will have an increase in their physical activity level.

    Baseline and 8 weeks

Study Arms (1)

MBSR

EXPERIMENTAL
Behavioral: Mindfulness Based Stress Reduction Program (MBSR)

Interventions

Mindfulness Based Stress Reduction Program (MBSR)BEHAVIORAL

Traditional eight-week MBSR Program.

MBSR

Eligibility Criteria

Age40 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roberto Benzo, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 28, 2010

Study Start

February 1, 2010

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

US(1)