Asthma and Mindfulness-Based Stress Reduction (MBSR)

• ClinicalTrials.gov Identifier: NCT00682669
• Recruitment Status: Completed
• First Posted: May 22, 2008
• Last Update Posted: August 19, 2011
• Sponsor: University of Massachusetts, Worcester
• Information provided by (Responsible Party): Lori Pbert, University of Massachusetts, Worcester

Tracking Information

• First Submitted Date: May 20, 2008
• First Posted Date: May 22, 2008
• Last Update Posted Date: August 19, 2011
• Study Start Date: September 2006
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 20, 2008): Quality of life and lung function. [ Time Frame: 10 week, 6- and 12-month post baseline ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 20, 2008): Reduce asthma symptoms, exacerbations and health care utilization [ Time Frame: 10-week, 6- and 12-month post baseline ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Asthma and Mindfulness-Based Stress Reduction (MBSR)
• Official Title: Asthma and Mindfulness-Based Stress Reduction (MBSR)
• Brief 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. 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Asthma

Intervention

• 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.

Study Arms

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 20, 2008): 83
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00682669
• Other Study ID Numbers: R21AT002938( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lori Pbert, University of Massachusetts, Worcester
• Original Responsible Party: Lori Pbert, Ph.D., University of Massachusetts Medical School
• Current Study Sponsor: University of Massachusetts, Worcester
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lori Pbert, PhD; University of Massachusetts, Worcester

• PRS Account: University of Massachusetts, Worcester
• Verification Date: August 2011