Asthma Symptom Management Through Mindfulness Training



Status:Active, not recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 2015
End Date:August 2020

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Asthma is one of the four most common adult chronic disorders. Supporting asthma patients in
improving their asthma control and symptoms as well as their quality of life are important
goals in clinical management. This study will test the effect of a widely-available
mindfulness training program in improving asthma control and symptoms and quality of life
among patients with asthma, and explore the relationship between asthma control and a number
of factors, including how well patients perceive their respiratory symptoms.

Asthma is one of the four most common adult chronic disorders. It affects 7.3% (16.4 million)
U.S. adults and costs $18 billion in direct healthcare costs and lost productivity. Control
of symptoms and improving patient's quality of life (QOL) are the goals in asthma management
and require patients to accurately identify their symptoms. But the low congruence between
patients' symptom reports and their pulmonary function leads to disease management errors.
The accuracy with which asthma patients recognize their symptoms is affected by emotional
factors, and because high negative affectivity is related to low interoceptive accuracy and
worse asthma symptoms and asthma physical health, the frequent mental distress prevalent
among asthmatics is thought to result in difficulty in distinguishing symptoms of
stress/distress from those of asthma. Mindfulness training teaches people to recognize and
distinguish among the components of experience (thoughts, feelings, sensations/symptoms) and
is associated with increased perceptual accuracy of respiratory resistance, and reduced
affective negativity. It thus has the potential to improve patient's discrimination between
asthma symptoms and stress/distress, resulting in improved asthma management, control and
QOL. A pilot randomized controlled trial (RCT) (N=84) of a widely-available mindfulness
training program (Mindfulness-Based Stress Reduction (MBSR)) to explore this hypothesis in
adults with mild, moderate or severe persistent asthma. Intent to treat analyses comparing
MBSR to an active control program showed clinically significant improvements in overall QOL
(p=0.01), as well as important improvements in asthma symptoms (p=0.009), reduced use of
asthma rescue medication (p=0.001), anxiety (p=0.05), perceived stress (p=0.01), and
mindfulness (p=0.01). Promising improvements in the percentage of patients with
well-controlled asthma also were found. All improvements were sustained 10 months
post-intervention. Widespread adoption of this promising adjunct intervention will require
sharper evidence regarding asthma control and symptoms. The primary aim is to test MBSR
against an active control on the key clinical outcomes of asthma control and symptoms using
gold standard measures with 256 adults with mild, moderate or severe asthma. And to evaluate
the program's effect on asthma QOL, lung function, cost-effectiveness, and the mediating
effect of respiratory interoceptive accuracy on asthma control, QOL, and medication use.
Assessments are at baseline, 6-, 12-, and 18-month follow-up. MBSR is available nationwide
and covered by many third-party payers. If sustained and credible improvements in asthma
control and symptoms are found, MBSR could be a useful adjunct to traditional medical
treatment and would have the potential for improving the lives of people with asthma. By
examining the mediating effects of psychosocial variables on asthma control, the study also
generates new knowledge on mechanisms of change and maintenance in mind-body and behavioral
programs in medicine.

Inclusion Criteria:

- Age 18 and older

- Documented diagnosis of asthma from a physician for greater than 12 months that
includes an objective indicator of bronchial hyperresponsiveness (positive
methacholine challenge test or > 12% improvement in forced expiratory volume in 1
second (FEV1) or forced vital capacity (FVC) in response to bronchodilator);

- Meets criteria for mild, moderate or severe asthma

- Treatment with inhaled corticosteroids for at least 12 weeks with stable dosing for
greater than 4 weeks;

- Able to read and understand English, and complete informed consent process and study
data collection procedures.

Exclusion Criteria:

- Current smoker or greater than 10 pack-year smoking history

- Diagnosis of asthma of intermittent severity

- Other lung diseases besides asthma

- Cancer, except non-melanoma skin cancer;

- Currently receiving treatment for symptomatic cardiovascular disease within past 6
months

- Current or recent (within the past 3 months) severe exacerbation of asthma requiring
hospitalization or oral glucocorticoids;

- Currently pregnant

- Major psychiatric disorders or psychiatric hospitalization in the last 2 years;

- Has taken the MBSR program in the past, and/or currently practicing meditation or yoga
on a regular basis.
We found this trial at
1
site
55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Principal Investigator: Lori Pbert, PhD
Phone: 508-856-3515
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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Worcester, MA
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