Asthma Symptom Management Through Mindfulness Training

May 20, 2022 updated by: Lori Pbert, University of Massachusetts, Worcester
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
233

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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. Lower scores indicate better outcome. Minimum = 0, Maximum = 6. Changes of 0.5 or greater in the score are considered important differences.
Baseline and 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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. Higher scores = better outcome, minimum score = 30, maximum score 210. Changes in scores of 0.5 or above represent clinically meaningful improvement in QoL.
Baseline and 18 months
Change From Baseline in Respiratory Interoceptive Accuracy at 18-months
Time Frame: Baseline 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. Higher score is better outcome, lower score is worse outcome. Lowest score is zero percent, highest score is 100% Time to complete: 30 minutes.
Baseline and 18-months
Change From Baseline in Percent Predicted Expiratory Volume at 18-months.
Time Frame: Baseline 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). The unit of measure is not a score on a scale but rather "percent predicted expiratory volume" to assess air flow limitation. 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. Higher scores mean better outcome.
Baseline and 18-months
Cost Per Change in Quality of Life (QOL)
Time Frame: 18 months
This outcome is the Incremental Cost Effectiveness Ratio (ICER). The ICER estimates how much the MBSR intervention costs, relative to the HLC intervention, to improve the outcome measure by 1 unit. The ICER is calculated by dividing the incremental cost by the incremental outcome. The Incremental cost is difference in total costs (sum of program costs and healthcare costs over 18 months, in U.S. dollars) between the MBSR and HLC groups. The Incremental outcome is the difference between the groups in the chosen measure of health outcome at 18 months (here, mean Asthma-related QoL (AQoL) questionnaire scores).
18 months
Cost in Change of Percent Predicted FEV
Time Frame: 18 months
This outcome is the Incremental Cost Effectiveness Ratio (ICER). The ICER estimates how much the MBSR intervention costs, relative to the HL intervention, to improve the outcome measure by 1 unit. The ICER is calculated by dividing the incremental cost by the incremental outcome. The incremental cost is the difference in total costs (sum of program costs and healthcare costs over 18 months, in U.S. dollars) between the MBSR and HLC groups. The incremental outcome is the difference between the groups at 18 months in the chosen measure of health outcome (here, mean Predicted FEV1 scores). This is not a scale.
18 months
Cost in Change of Asthma Control
Time Frame: 18 months
This outcome is the Incremental Cost Effectiveness Ratio (ICER). The ICER estimates how much the MBSR intervention costs, relative to the HL intervention, to improve the outcome measure by 1 unit. The ICER is calculated by dividing the Incremental cost by the incremental outcome. The incremental cost is the difference in total costs (sum of program costs and healthcare costs over 18 months, in U.S. dollars) between the MBSR and HLC groups. The incremental outcome is the difference between the groups in the chosen measure of health outcome 18 months (here, mean Asthma Control Score). This is not a scale.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Miriam Hospital
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Carmody, PhD, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H00006718
  • R01AT008393 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings