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Asthma Symptom Management Through Mindfulness Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02275559
Recruitment Status : Active, not recruiting
First Posted : October 27, 2014
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
The Miriam Hospital
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Lori Pbert, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Mindfulness Based Stress Reduction (MBSR) Behavioral: Healthy Living Course (HLC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Asthma Symptom Management Through Mindfulness Training
Actual Study Start Date : August 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Behavioral: Mindfulness Based Stress Reduction (MBSR)
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.

Active Comparator: Healthy Living Course (HLC)
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Behavioral: Healthy Living Course (HLC)
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support




Primary Outcome Measures :
  1. Change from baseline in asthma control at 18 months [ Time Frame: Baseline and 18 months ]
    Asthma control will be assessed using the Asthma Control Questionnaire (ACQ). The ACQ is a 7-item validated measure that assesses the 5 asthma symptoms considered most important and most used by clinicians for evaluating asthma control, along with use of short-acting beta-agonist and FEV1 percent predicted. Patients recall their symptoms and short-acting beta-agonist use during the previous week; FEV1 is obtained from spirometry. All seven questions are scored on a 7-point scale (0=good control, 6=poor control), and the overall score (range 0-6) is the mean of the seven responses. Changes of 0.5 or greater in the score are considered important differences.


Secondary Outcome Measures :
  1. Change from baseline in asthma-related quality of life at 18 months [ Time Frame: Baseline and 18 months ]
    Asthma-related quality of life will be assessed using the Asthma-related QoL (AQoL) measure.The AQoL has 30 items assessing impairment in 4 areas of function shown to be important to the QoL of adult patients with asthma (activity limitations, asthma symptoms, emotional function and environmental exposure). Overall QoL is computed by averaging scores on the 4 domains. Items assess the degree to which important activities have been limited by asthma during the last 2 weeks on a 7-point scale (1= maximal impairment, 7= no impairment). Shown to be valid, reliable and sufficiently sensitive to changes in asthma symptoms to capture the effects of an intervention in a clinical trial. Changes in scores of 0.5 or above represent clinically meaningful improvement in QoL.

  2. Change from baseline in respiratory interoceptive accuracy at 6-, 12- and 18-months [ Time Frame: Baseline, 6-, 12- and 18-months ]
    Respiratory interoceptive accuracy will be measured using the Breath Perception Discrimination Test (BPDT). The BPDT measures ability to detect small changes in resistive load. This test will be done in the Pulmonary Diagnostic Laboratory at each site. During the test period, the presentation of the resistor will be announced at the onset of a new inspiration for the duration of one full breath cycle. At the conclusion of the breath cycle, participants pause for 5 normal breaths, at which point the next resistor in the block is presented. The test will be divided into 6 blocks during which there is a random presentation of each resistor so that participants carry out 30 ratings (6 for each condition) over the course of the test. Time to complete: 30 minutes.

  3. Change from baseline in lung function at 6-, 12- and 18-months [ Time Frame: Baseline, 6-, 12- and 18-months ]
    Lung function will be assessed via spirometry. Spirometry assesses the level of air flow limitation according to the forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC). Measurement will be done in the site Pulmonary Diagnostic Laboratories according to American Thoracic Society guidelines before and after inhalation of bronchodilator. This includes instructing participants to not take a bronchodilator at least 4 hours prior to their spirometry, and assessing lung function both before, and then 30 minutes after bronchodilator to assess best lung function and responsiveness to bronchodilator therapy. The team pulmonologist at each site will interpret all spirometry tests.

  4. Cost-effectiveness [ Time Frame: 18 months ]
    Cost effectiveness will include collection of the following data. The number of moderate and severe exacerbations, asthma-related regularly scheduled office visits, unscheduled office visits (acute care visits), hospitalizations, emergency room visits, need for intubation or mechanical ventilation, and calls to their physician during the prior 6 months at baseline, 6-, 12- and 18-month follow-up and associated clinic and hospital costs will be determined by self-report and hospital records.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275559


Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
The Miriam Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: James Carmody, PhD University of Massachusetts, Worcester
Principal Investigator: Lori Pbert, PhD University of Massachusetts, Worcester

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Responsible Party: Lori Pbert, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02275559     History of Changes
Other Study ID Numbers: H00006718
R01AT008393 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases