Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-04 @ 5:20 PM
Study NCT ID:
NCT00682669
Status:
COMPLETED
Last Update Posted:
2011-08-19
First Post:
2008-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asthma and Mindfulness-Based Stress Reduction (MBSR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-18', 'studyFirstSubmitDate': '2008-05-20', 'studyFirstSubmitQcDate': '2008-05-20', 'lastUpdatePostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life and lung function.', 'timeFrame': '10 week, 6- and 12-month post baseline'}], 'secondaryOutcomes': [{'measure': 'Reduce asthma symptoms, exacerbations and health care utilization', 'timeFrame': '10-week, 6- and 12-month post baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'Mindfulness-based stress reduction', 'Peak expiratory flow rate', 'Spirometry', 'Quality of life'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '22544892', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented diagnosis of asthma from their physician\n* meet criteria for mild persistent or moderate persistent asthma\n* able to read and understand English\n* able to complete informed consent process and study data collection procedures\n* 21 or older\n\nExclusion Criteria:\n\n* current smoker\n* other lung diseases besides asthma\n* cancer, except non-melanoma skin cancer\n* currently receiving treatment for symptomatic cardiovascular disease\n* on psychotropic medications in the prior 6 months\n* psychiatric hospitalization in the last 2 years\n* has taken the MBSR program in the past\n* currently practicing meditation or yoga on a regular basis'}, 'identificationModule': {'nctId': 'NCT00682669', 'briefTitle': 'Asthma and Mindfulness-Based Stress Reduction (MBSR)', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Asthma and Mindfulness-Based Stress Reduction (MBSR)', 'orgStudyIdInfo': {'id': 'R21AT002938', 'link': 'https://reporter.nih.gov/quickSearch/R21AT002938', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBSR', 'description': '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.', 'interventionNames': ['Behavioral: MBSR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HLC', 'description': 'A Healthy Living Course (HLC) consisting of an 8-week program of lectures and discussion on health-related topics.', 'interventionNames': ['Behavioral: HLC']}], 'interventions': [{'name': 'MBSR', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['MBSR']}, {'name': 'HLC', 'type': 'BEHAVIORAL', 'description': 'An 8-week program consisting of lectures and discussion of health-related topics.', 'armGroupLabels': ['HLC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Lori Pbert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Lori Pbert', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}