Mindfulness Based Stress Reduction in COPD | NCT01058499

Studies
Mindfulness Based Stress Reduction in COPD

NCT01058499

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 21, 2016Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease
COPD

Interventions

Mindfulness Based Stress Reduction Program (MBSR)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jan 27, 2010

First Submission Date that Met QC Criteria

Jan 27, 2010

First Posted Date

Jan 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2016

Last Update Posted Date

Mar 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MBSR	Experimental		Behavioral: Mindfulness Based Stress Reduction Program (MBSR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness Based Stress Reduction Program (MBSR)	Behavioral	Traditional eight-week MBSR Program.	MBSR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Participants in the MBSR for COPD will have an increase in their physical activity level.		Baseline and 8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberto Benzo, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided