Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-24 @ 9:28 PM
Study NCT ID:
NCT02275559
Status:
COMPLETED
Last Update Posted:
2022-05-23
First Post:
2014-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Asthma Symptom Management Through Mindfulness Training
Sponsor:
University of Massachusetts, Worcester
Organization:
Study Overview
Official Title:
Asthma Symptom Management Through Mindfulness Training
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AT008393 | NIH | None | https://reporter.nih.gov/quic… | View |