Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD)

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01577329
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Behavioral: Mindfulness meditation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Mindfulness Mediation Intervention in COPD
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Changes in Respiratory Rate [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roxane Raffin Chan, RN, PhD, University of Michigan
• ClinicalTrials.gov Identifier: NCT01577329
• Other Study ID Numbers: um-nursing-meditation
• First Posted: Apr 13, 2012
• Last Update Posted: Aug 2, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Roxane Raffin Chan, RN, PhD, 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

Study Results

Participant Flow

Recruitment Details	Change was made to original number of participants due to human error. 51 persons were approached regarding possible enrollment.

Arm/Group Title	Mindfulness Meditation Class	Wait List
Arm/Group Description	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. 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.	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.
Period Title: Overall Study
STARTED	19	22
COMPLETED	16	22
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Mindfulness Meditation Class	Wait List	Total
Arm/Group Description	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. 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.	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.	Total of all reporting groups
Overall Participants	19	22	41
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 15.8%	1 4.5%	4 9.8%
>=65 years	16 84.2%	21 95.5%	37 90.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.3 (5.2)	68.7 (4.8)	69.5 (7.9)
Sex: Female, Male (Count of Participants)
Female	13 68.4%	14 63.6%	27 65.9%
Male	6 31.6%	8 36.4%	14 34.1%
Region of Enrollment (Count of Participants)
United States	19 100%	22 100%	41 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Respiratory Rate
Description	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.
Time Frame	baseline and at week eight

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Meditation Class	Wait List
Arm/Group Description	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. 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.	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.
Measure Participants	16	22
Baseline	15.93 (2.82)	17.18 (6.44)
Follow-up	21.31 (3.05)	18.73 (4.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindfulness Meditation Class, Wait List
	Comments	This is a calculated P value comparing two groups at baseline and follow-up
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	This is a calculated P value and was not adjusted for multiple comparisons.
	Method	ANOVA
	Comments

Adverse Events

Time Frame	Eight weeks
Arm/Group Title	Mindfulness Meditation Class		Wait List
Arm/Group Description	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. 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.		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.
All Cause Mortality
	Mindfulness Meditation Class		Wait List
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/22 (0%)
Serious Adverse Events
	Mindfulness Meditation Class		Wait List
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness Meditation Class		Wait List
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.