Clinical trial NCT02275559: Asthma Symptom Management Through Mindfulness Training
Official title: Asthma Symptom Management Through Mindfulness Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-10-27
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Asthma Control at 18 Months
timeFrame: Baseline and 18 months
Secondary outcomes:
measure: Change From Baseline in Asthma-related Quality of Life at 18 Months
timeFrame: Baseline and 18 months
measure: Change From Baseline in Respiratory Interoceptive Accuracy at 18-months
timeFrame: Baseline and 18-months
measure: Change From Baseline in Percent Predicted Expiratory Volume at 18-months.
timeFrame: Baseline and 18-months
measure: Cost Per Change in Quality of Life (QOL)
timeFrame: 18 months
measure: Cost in Change of Percent Predicted FEV
timeFrame: 18 months
measure: Cost in Change of Asthma Control
timeFrame: 18 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: James Carmody, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Lori Pbert, PhD
role: PRINCIPAL_INVESTIGATOR
References: