Asthma Symptom Management Through Mindfulness Training

NCT02275559 | Completed Results DMC

• 2 other identifiers: H00006718R01AT008393
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is one of the four most common adult chronic disorders. Supporting asthma patients in improving their asthma control and symptoms as well as their quality of life are important goals in clinical management. This study will test the effect of a widely-available mindfulness training program in improving asthma control and symptoms and quality of life among patients with asthma, and explore the relationship between asthma control and a number of factors, including how well patients perceive their respiratory symptoms.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Asthma Control at 18 Months

  Asthma control will be assessed using the Asthma Control Questionnaire (ACQ). The ACQ is a 7-item validated measure that assesses the 5 asthma symptoms considered most important and most used by clinicians for evaluating asthma control, along with use of short-acting beta-agonist and FEV1 percent predicted. Patients recall their symptoms and short-acting beta-agonist use during the previous week; FEV1 is obtained from spirometry. All seven questions are scored on a 7-point scale (0=good control, 6=poor control), and the overall score (range 0-6) is the mean of the seven responses. Lower scores indicate better outcome. Minimum = 0, Maximum = 6. Changes of 0.5 or greater in the score are considered important differences.

  Baseline and 18 months

Secondary Outcomes (6)

• Change From Baseline in Asthma-related Quality of Life at 18 Months

  Baseline and 18 months

• Change From Baseline in Respiratory Interoceptive Accuracy at 18-months

  Baseline and 18-months

• Change From Baseline in Percent Predicted Expiratory Volume at 18-months.

  Baseline and 18-months

• Cost Per Change in Quality of Life (QOL)

  18 months

• Cost in Change of Percent Predicted FEV

  18 months

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.

Behavioral: Mindfulness Based Stress Reduction (MBSR)

Healthy Living Course (HLC)

ACTIVE COMPARATOR

The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support

Behavioral: Healthy Living Course (HLC)

Interventions

Mindfulness Based Stress Reduction (MBSR) BEHAVIORAL

Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.

Mindfulness Based Stress Reduction

Healthy Living Course (HLC) BEHAVIORAL

The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support

Healthy Living Course (HLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and older
• Documented diagnosis of asthma from a physician for greater than 12 months that includes an objective indicator of bronchial hyperresponsiveness (positive methacholine challenge test or \> 12% improvement in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) in response to bronchodilator);
• Meets criteria for mild, moderate or severe asthma
• Treatment with inhaled corticosteroids for at least 12 weeks with stable dosing for greater than 4 weeks;
• Able to read and understand English, and complete informed consent process and study data collection procedures.

You may not qualify if:

• Current smoker or greater than 10 pack-year smoking history
• Diagnosis of asthma of intermittent severity
• Other lung diseases besides asthma
• Cancer, except non-melanoma skin cancer;
• Currently receiving treatment for symptomatic cardiovascular disease within past 6 months
• Current or recent (within the past 3 months) severe exacerbation of asthma requiring hospitalization or oral glucocorticoids;
• Currently pregnant
• Major psychiatric disorders or psychiatric hospitalization in the last 2 years;
• Has taken the MBSR program in the past, and/or currently practicing meditation or yoga on a regular basis.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• The Miriam Hospital: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr James Carmody
• Organization: UMass Chan Medical School

james.carmody@umassmed.edu

5088561205

Study Officials

• James Carmody, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Lori Pbert, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 27, 2014
• Study Start: August 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 23, 2022
• Results First Posted: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)