AsthmaNCT02275559
Asthma Symptom Management Through Mindfulness Training
A study testing Mindfulness Based Stress Reduction (MBSR) and Healthy Living Course (HLC) in people with Asthma, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR) and Healthy Living Course (HLC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Mindfulness Based Stress Reduction (MBSR), Healthy Living Course (HLC)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction (MBSR)Behavioural
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.
Healthy Living Course (HLC)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | 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. Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR) |
| Healthy Living Course (HLC) | Active comparator | 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 Receives: Behavioral: Healthy Living Course (HLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Asthma Control at 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.
Measured: Baseline and 18 months
Secondary outcomes (6)
Change From Baseline in Asthma-related Quality of Life at 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.
Measured: Baseline and 18 months
Change From Baseline in Respiratory Interoceptive Accuracy at 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.
Measured: Baseline and 18-months
Change From Baseline in Percent Predicted Expiratory Volume at 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.
Measured: Baseline and 18-months
Cost Per Change in Quality of Life (QOL)
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).
Measured: 18 months
Cost in Change of Percent Predicted FEV
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.
Measured: 18 months
Cost in Change of Asthma Control
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startAug 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Lori Pbert, University of Massachusetts, Worcester
- Investigators
- James Carmody, PhD, Principal investigator, University of Massachusetts, WorcesterLori Pbert, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275559
- Sponsor's protocol ID
- H00006718
- Other IDs
- R01AT008393
- Status last verified
- May 2022
- First submitted
- 6 Oct 2014
- Last updated
- 23 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Symptom Management Through Mindfulness Training
- ClinicalTrials.gov ID
- NCT02275559
- Acronym / sponsor ID
- H00006718
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- The Miriam Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Posted 23 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | 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. |
| Healthy Living Course (HLC) | Active comparator | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness Based Stress Reduction |
| 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 | Behavioural | Healthy Living Course (HLC) |
Primary outcome
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.
6 secondary outcomes
Change From Baseline in Asthma-related Quality of Life at 18 Months
Time frame: Baseline and 18 months
Change From Baseline in Respiratory Interoceptive Accuracy at 18-months
Time frame: Baseline and 18-months
Change From Baseline in Percent Predicted Expiratory Volume at 18-months.
Time frame: Baseline and 18-months
Cost Per Change in Quality of Life (QOL)
Time frame: 18 months
Cost in Change of Percent Predicted FEV
Time frame: 18 months
Cost in Change of Asthma Control
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Carmody, PhD principal investigator
University of Massachusetts, Worcester
Lori Pbert, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction (MBSR) and Healthy Living Course (HLC) in people with Asthma, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Asthma Control at 18 Months (time frame: Baseline and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.