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Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Raffin Chan, University of Michigan
ClinicalTrials.gov Identifier:
NCT01577329
First received: April 11, 2012
Last updated: April 21, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to assess the feasibility and potential impact of an eight week program of meditation on expiratory time, anxiety and dyspnea in people with COPD.

Condition Intervention
Chronic Obstructive Pulmonary Disease Behavioral: Mindfulness meditation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindfulness Mediation Intervention in COPD

Resource links provided by NLM:


Further study details as provided by Roxane Raffin Chan, University of Michigan:

Primary Outcome Measures:
  • Changes in Respiratory Rate [ Time Frame: baseline and at week eight ]
    Breathing patterns will be measured at baseline using inductive plethysmography at baseline and at week eight. During that eight week time period the treatment group will have been exposed to a once a week mindfulness meditation class and the control group will have been exposed to health care as usual.


Enrollment: 41
Study Start Date: October 2011
Study Completion Date: July 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mindfulness meditation class
Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.
Behavioral: Mindfulness meditation
Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.
No Intervention: wait list
Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.

Detailed Description:
Chronic Obstructive Pulmonary Disease is a progressive multi-dimensional disease with a complex network of somatic and affective components. Anxiety is a common experience for persons with COPD both as a reaction to dyspnea (48) and as a separate co-morbid condition (10, 26). The presence of anxiety magnifies COPD symptoms and further impairs physical functioning (53). Both anxiety and COPD alter breathing patterns similarly causing irregular rapid shallow breathing at rest, which is inefficient and cannot adequately respond to increases in ventilatory demands from physical or emotional activity (121). Both COPD and anxiety are also associated with changes in neurological functioning. Whereas anxiety tends to be associated with increased amygdala activity (54), COPD is associated with a decrease in frontal cortex functioning (25, 28, 122). Persons with COPD who experience anxiety are less able to correctly process the level of physical and emotional demand for any given situation and their ability to meet that demand (46, 123). Pulmonary rehabilitation addresses both the physical and emotional symptoms of COPD, however gains in function are quickly lost over time (4). Evidence suggests that mindfulness based meditation can alter neural pathways to facilitate processing of emotions and increase quality of life for persons with COPD. The overall objective of this study is to assess the ability of persons with COPD to participate in a mindfulness meditation intervention and to examine the impact of mindfulness meditation on their anxiety levels and global sense of coherence. A modified version of Antonovsky's sense of coherence model will be used as the framework for this study. We will address the specific aims: 1) to determine the effects of mindfulness meditation on breathing patterns; 2) To determine the effects of mindfulness meditation on anxiety levels; 3) To determine self-reported adherence rates following an eight-week small group instructional course on mindfulness meditation, and 4) To determine the effects of mindfulness meditation on global sense of coherence levels in persons with COPD. The National Center for Complementary and Alternative Medicine identifies meditation as a form of CAM that focuses on the interaction among the brain, body, mind and behavior that is already practiced by 8% of persons who participate in CAM therapy. Meditation is rated a special priority research area by NCCAM.
  Eligibility

Ages Eligible for Study:   40 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any stage of Chronic Obstructive Pulmonary Disease
  • Able to read and write English

Exclusion Criteria:

  • Severe mental disability
  • Inability to attend
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577329

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Roxane R Chan, RN, PhD (c) University of Michigan
  More Information

Publications:
Responsible Party: Roxane Raffin Chan, RN, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01577329     History of Changes
Other Study ID Numbers: um-nursing-meditation
Study First Received: April 11, 2012
Results First Received: November 22, 2016
Last Updated: April 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Roxane Raffin Chan, University of Michigan:
meditation
Chronic Obstructive Pulmonary Disease
Mindfulness
Anxiety
Breathing Patterns

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

ClinicalTrials.gov processed this record on September 21, 2017