Asthma and Mindfulness-Based Stress Reduction (MBSR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lori Pbert, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00682669
First received: May 20, 2008
Last updated: August 18, 2011
Last verified: August 2011

May 20, 2008
August 18, 2011
September 2006
January 2009   (final data collection date for primary outcome measure)
Quality of life and lung function. [ Time Frame: 10 week, 6- and 12-month post baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00682669 on ClinicalTrials.gov Archive Site
Reduce asthma symptoms, exacerbations and health care utilization [ Time Frame: 10-week, 6- and 12-month post baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Asthma and Mindfulness-Based Stress Reduction (MBSR)
Asthma and Mindfulness-Based Stress Reduction (MBSR)

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.

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Asthma
  • Behavioral: MBSR
    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.
  • Behavioral: HLC
    An 8-week program consisting of lectures and discussion of health-related topics.
  • Experimental: MBSR
    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.
    Intervention: Behavioral: MBSR
  • Active Comparator: HLC
    A Healthy Living Course (HLC) consisting of an 8-week program of lectures and discussion on health-related topics.
    Intervention: Behavioral: HLC
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00682669
R21AT002938
Yes
Lori Pbert, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Lori Pbert, PhD University of Massachusetts, Worcester
University of Massachusetts, Worcester
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP