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
  Purpose

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.


Condition Intervention Phase
Asthma
Behavioral: MBSR
Behavioral: HLC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Asthma and Mindfulness-Based Stress Reduction (MBSR)

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Quality of life and lung function. [ Time Frame: 10 week, 6- and 12-month post baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduce asthma symptoms, exacerbations and health care utilization [ Time Frame: 10-week, 6- and 12-month post baseline ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: September 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: HLC
A Healthy Living Course (HLC) consisting of an 8-week program of lectures and discussion on health-related topics.
Behavioral: HLC
An 8-week program consisting of lectures and discussion of health-related topics.

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682669

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Lori Pbert, PhD University of Massachusetts, Worcester
  More Information

No publications provided by University of Massachusetts, Worcester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lori Pbert, Professor of Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00682669     History of Changes
Other Study ID Numbers: R21AT002938
Study First Received: May 20, 2008
Last Updated: August 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Asthma
Mindfulness-based stress reduction
Peak expiratory flow rate
Spirometry
Quality of life

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014