AsthmaPhase 1/2NCT00682669
Asthma and Mindfulness-Based Stress Reduction (MBSR)
A Phase 1/2 study testing MBSR and 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 chronic disorders in adults, affecting 14 million adults in the United States and costing an estimated 7.9 billion dollars in medical care and 5.3 billion dollars in lost work or school. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- MBSR and HLC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- documented diagnosis of asthma from their physician
- meet criteria for mild persistent or moderate persistent asthma
- able to read and understand English
- able to complete informed consent process and study data collection procedures
- 21 or older
Who cannot join
- current smoker
- other lung diseases besides asthma
- cancer, except non-melanoma skin cancer
- currently receiving treatment for symptomatic cardiovascular disease
- on psychotropic medications in the prior 6 months
- psychiatric hospitalization in the last 2 years
- has taken the MBSR program in the past
- 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 chronic disorders in adults, affecting 14 million adults in the United States and costing an estimated 7.9 billion dollars in medical care and 5.3 billion dollars in lost work or school. About 40% of asthmatics report using some form of complementary and alternative medicine approach to help reduce their asthma symptoms, but there is little evidence for their effectiveness. Mindfulness-based stress reduction (MBSR) is a group based program shown to reduce medical symptoms and improve quality of life for patients with many different chronic diseases. The goals of the proposed randomized controlled trial are to collect preliminary data on the effect of MBSR on quality of life, symptoms, and lung function in mild and moderate-severity asthmatics and to refine recruitment and data collection procedures for a future, larger clinical trial.
Read the detailed description
Asthma is a chronic respiratory disease that affects 7% or 14 million adults in the United States. It is one of the four most common chronic disorders in adults, costing an estimated 7.9 billion dollars in medical care and 5.3 billion dollars in lost work or school. Approximately 40% of asthmatics report using some form of complementary and alternative medicine (CAM) approach to help alleviate their asthma symptoms, but there is little evidence for their effectiveness. Breathing and relaxation techniques, including yoga appear most promising. Mindfulness-based stress reduction (MBSR) is a group-based program developed at the University of Massachusetts Medical School (UMMS) that focuses on the cultivation of mindfulness through formal meditation practices and the integration of mindfulness into everyday life as a coping resource to deal with physical symptoms, chronic medical conditions, and difficult emotional situations. MBSR has been shown to be an effective adjunctive intervention in reducing medical symptoms for a broad range of stress-related disorders and chronic diseases, reducing psychological distress anxiety and depression, and improving quality of life. A small preliminary study conducted by our research team found improvements in measures of quality of life, locus of control, stress, and anxiety immediately following the completion of the MBSR program.
The overall goal of the proposed two year exploratory study is to conduct a randomized controlled trial (RCT) to test and optimize recruitment and data collection procedures and to collect preliminary data on the effect of MBSR on behavioral and psychological aspects of asthma and lung function to support justification for a larger clinical trial should the results of this study be promising. Eighty-two adults ages 21 and older with a physician-documented diagnosis of asthma classified as either mild or moderate documented will be recruited for seventy participants at final follow-up. Participants will be randomly assigned to one of two conditions stratified by asthma severity: (1) MBSR, or (2) Healthy Living Course (HLC) attention control condition. Participant assessments will occur at study entry (baseline) and at 10-week, 6- and 12-month follow-up. The primary aim of the project is to evaluate the efficacy of the MBSR program in improving quality of life and lung function as assessed by change from baseline to two-week average morning peak expiratory flow (PEF) compared to HLC participants. Secondary aims are to evaluate the effect of the MBSR program on reducing asthma rescue medication use, frequency of asthma exacerbations (prednisone therapy), asthma symptoms, healthcare utilization, number of days of work or school missed, peak expiratory flow (PEF) variation, and psychological distress, and in improving asthma control, asthma-related internal locus of control, and lung function as assessed by spirometry (FEV1).
- Conditions
- Asthma
- Being tested
- MBSR, HLC
- Keywords
- Asthma, Mindfulness-based stress reduction, Peak expiratory flow rate, Spirometry, Quality of life
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
A mindfulness-based stress reduction (MBSR) program consisting of an 8-week, 9-session intervention based on systematic and intensive training in mindfulness meditation and mindful hatha yoga and their application to every day life.
HLCBehavioural
An 8-week program consisting of lectures and discussion of health-related topics.
| Study group | Role | What they receive |
|---|---|---|
| MBSR | Experimental | A mindfulness-based stress reduction (MBSR) program consisting of an 8-week, 9-session intervention based on systematic and intensive training in mindfulness meditation and mindful hatha yoga and their application to every day life. Receives: Behavioral: MBSR |
| HLC | Active comparator | A Healthy Living Course (HLC) consisting of an 8-week program of lectures and discussion on health-related topics. Receives: Behavioral: HLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life and lung function.
Measured: 10 week, 6- and 12-month post baseline
Secondary outcomes (1)
Reduce asthma symptoms, exacerbations and health care utilization
Measured: 10-week, 6- and 12-month post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startSep 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Pbert, University of Massachusetts, Worcester
- Investigators
- Lori Pbert, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682669
- Sponsor's protocol ID
- R21AT002938
- Status last verified
- Aug 2011
- First submitted
- 20 May 2008
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pbert L, Madison JM, Druker S, Olendzki N, Magner R, Reed G, Allison J, Carmody J. Effect of mindfulness training on asthma quality of life and lung function: a randomised controlled trial. Thorax. 2012 Sep;67(9):769-76. doi: 10.1136/thoraxjnl-2011-200253. Epub 2012 Apr 27.
PubMed 22544892
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma and Mindfulness-Based Stress Reduction (MBSR)
- ClinicalTrials.gov ID
- NCT00682669
- Acronym / sponsor ID
- R21AT002938
- Conditions
- Asthma
- Keywords
- Asthma, Mindfulness-based stress reduction, Peak expiratory flow rate, Spirometry, Quality of life
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
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 chronic disorders in adults, affecting 14 million adults in the United States and costing an estimated 7.9 billion dollars in medical care and 5.3 billion dollars in lost work or school. About 40% of asthmatics report using some form of complementary and alternative medicine approach to help reduce their asthma symptoms, but there is little evidence for their effectiveness. Mindfulness-based stress reduction (MBSR) is a group based program shown to reduce medical symptoms and improve quality of life for patients with many different chronic diseases. The goals of the proposed randomized controlled trial are to collect preliminary data on the effect of MBSR on quality of life, symptoms, and lung function in mild and moderate-severity asthmatics and to refine recruitment and data collection procedures for a future, larger clinical trial.
Detailed description
Asthma is a chronic respiratory disease that affects 7% or 14 million adults in the United States. It is one of the four most common chronic disorders in adults, costing an estimated 7.9 billion dollars in medical care and 5.3 billion dollars in lost work or school. Approximately 40% of asthmatics report using some form of complementary and alternative medicine (CAM) approach to help alleviate their asthma symptoms, but there is little evidence for their effectiveness. Breathing and relaxation techniques, including yoga appear most promising. Mindfulness-based stress reduction (MBSR) is a group-based program developed at the University of Massachusetts Medical School (UMMS) that focuses on the cultivation of mindfulness through formal meditation practices and the integration of mindfulness into everyday life as a coping resource to deal with physical symptoms, chronic medical conditions, and difficult emotional situations. MBSR has been shown to be an effective adjunctive intervention in reducing medical symptoms for a broad range of stress-related disorders and chronic diseases, reducing psychological distress anxiety and depression, and improving quality of life. A small preliminary study conducted by our research team found improvements in measures of quality of life, locus of control, stress, and anxiety immediately following the completion of the MBSR program.
The overall goal of the proposed two year exploratory study is to conduct a randomized controlled trial (RCT) to test and optimize recruitment and data collection procedures and to collect preliminary data on the effect of MBSR on behavioral and psychological aspects of asthma and lung function to support justification for a larger clinical trial should the results of this study be promising. Eighty-two adults ages 21 and older with a physician-documented diagnosis of asthma classified as either mild or moderate documented will be recruited for seventy participants at final follow-up. Participants will be randomly assigned to one of two conditions stratified by asthma severity: (1) MBSR, or (2) Healthy Living Course (HLC) attention control condition. Participant assessments will occur at study entry (baseline) and at 10-week, 6- and 12-month follow-up. The primary aim of the project is to evaluate the efficacy of the MBSR program in improving quality of life and lung function as assessed by change from baseline to two-week average morning peak expiratory flow (PEF) compared to HLC participants. Secondary aims are to evaluate the effect of the MBSR program on reducing asthma rescue medication use, frequency of asthma exacerbations (prednisone therapy), asthma symptoms, healthcare utilization, number of days of work or school missed, peak expiratory flow (PEF) variation, and psychological distress, and in improving asthma control, asthma-related internal locus of control, and lung function as assessed by spirometry (FEV1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: MBSRA mindfulness-based stress reduction (MBSR) program consisting of an 8-week, 9-session intervention based on systematic and intensive training in mindfulness meditation and mindful hatha yoga and their application to every day life. |
| HLC | Active comparator | Behavioral: HLCA Healthy Living Course (HLC) consisting of an 8-week program of lectures and discussion on health-related topics. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- documented diagnosis of asthma from their physician
- meet criteria for mild persistent or moderate persistent asthma
- able to read and understand English
- able to complete informed consent process and study data collection procedures
- 21 or older
Key exclusion criteria (8 listed)
- current smoker
- other lung diseases besides asthma
- cancer, except non-melanoma skin cancer
- currently receiving treatment for symptomatic cardiovascular disease
- on psychotropic medications in the prior 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 |
|---|---|---|
| MBSRA mindfulness-based stress reduction (MBSR) program consisting of an 8-week, 9-session intervention based on systematic and intensive training in mindfulness meditation and mindful hatha yoga and their application to every day life. | Behavioural | MBSR |
| HLCAn 8-week program consisting of lectures and discussion of health-related topics. | Behavioural | HLC |
Primary outcome
Quality of life and lung function.
Time frame: 10 week, 6- and 12-month post baseline
1 secondary outcome
Reduce asthma symptoms, exacerbations and health care utilization
Time frame: 10-week, 6- and 12-month post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Derived from this study: PubMed 22544892Pbert L, Madison JM, Druker S, Olendzki N, Magner R, Reed G, Allison J, Carmody J. Effect of mindfulness training on asthma quality of life and lung function: a randomised controlled trial. Thorax. 2012 Sep;67(9):769-76. doi: 10.1136/thoraxjnl-2011-200253. Epub 2012 Apr 27.
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
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.
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 Phase 1/2 study testing MBSR and 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 8 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 19 Aug 2011. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life and lung function. (time frame: 10 week, 6- and 12-month post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00682669, which also lists 1 linked publication.
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 19 Aug 2011; AzTrials last refreshed its copy on 1 Nov 2026.