Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Roxane Raffin Chan, University of Michigan
ClinicalTrials.gov Identifier:
NCT01577329
First received: April 11, 2012
Last updated: April 12, 2012
Last verified: April 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mindfulness Mediation Intervention in COPD

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Changes in respiration expiration time [ Time Frame: baseline and at week eight ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 56
Study Start Date: October 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (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.
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.

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 and older
Genders Eligible for Study:   Both
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

Contacts
Contact: Roxane R Chan, RN, PhD (c) 734-478-0170 rrchan@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Roxane R Chan, RN, PhD (c)    734-478-0170    rrchan@umich.edu   
Contact: Janet L Larson, RN, PhD    734-763-0002    janetlar@umich.edu   
Principal Investigator: Roxane R Chan, RN, PhD (c)         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Roxane R Chan, RN, PhD (c) University of Michigan
  More Information

No publications provided

Responsible Party: Roxane Raffin Chan, RN, PhD (c), University of Michigan
ClinicalTrials.gov Identifier: NCT01577329     History of Changes
Other Study ID Numbers: um-nursing-meditation
Study First Received: April 11, 2012
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014