NCT00682669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for phase_1 asthma

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_1 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 19, 2011

Status Verified

August 1, 2011

Enrollment Period

2.3 years

First QC Date

May 20, 2008

Last Update Submit

August 18, 2011

Conditions

Asthma

Keywords

AsthmaMindfulness-based stress reductionPeak expiratory flow rateSpirometryQuality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life and lung function.

    10 week, 6- and 12-month post baseline

Secondary Outcomes (1)

  • Reduce asthma symptoms, exacerbations and health care utilization

    10-week, 6- and 12-month post baseline

Study Arms (2)

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.

Behavioral: MBSR

HLC

ACTIVE COMPARATOR

A Healthy Living Course (HLC) consisting of an 8-week program of lectures and discussion on health-related topics.

Behavioral: HLC

Interventions

MBSRBEHAVIORAL

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.

MBSR
HLCBEHAVIORAL

An 8-week program consisting of lectures and discussion of health-related topics.

HLC

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • 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.

    PMID: 22544892DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lori Pbert, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

September 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 19, 2011

Record last verified: 2011-08

Locations

US(1)