Mindfulness to Mitigate the Effect of Anxiety-depression-fear in Chronic Obstructive Pulmonary Disease (COPD)

Mindfulness to Mitigate the Effect of Anxiety-depression-fear in COPD

People with COPD have a greater risk for symptoms of depression, anxiety, and fear of breathlessness. Those emotions are independently associated with lower physical activity, poorer quality of life, and higher hospitalization and exacerbations; all independent predictors of survival and costs. There is a lack of treatment options to be routinely used in primary clinics for patients with COPD. Systematic reviews suggest that interventions that promote an accepting mode of response, such as mindfulness, might be more appropriate and effective for managing psychological distress in COPD patients, especially breathing-related anxiety.

Hypothesis: A home-based 8-week Mindfulness-Based Stress Reduction (MBSR) for COPD targeted to individuals with symptoms of depression, anxiety, or fear of breathlessness delivered by a mindfulness coach using a combination of in-person sessions and remote video call sessions will be effective in improving emotional and overall quality of life, and measured physical activity.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Mindfulness

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Lung disease diagnosis
• Demonstrated competence in proposed technology
• Current or past smoking status
• Patient Health Questionnaire-2 (PHQ-2) or Generalized Anxiety Disorder scale (GAD-2) score >2 points or answering yes to a validated question of fear of being breathless ("Do you experience fear, or panic when you have difficulty getting your breath a good bit of the time?")

Exclusion criteria:

• High likelihood of non-compliance or low confidence using the technology
• Patients currently in pulmonary rehabilitation
• Inability to walk
• Prescribed antidepressant or antianxiety medication within last month
• Documented substance abuse
• Cognitive impairment as defined by the Mini-Mental test score < 24.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness	Behavioral: Mindfulness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life as measured by the Chronic Respiratory Questionnaire	The Chronic Respiratory Disease Questionnaire is a disease-specific health-related quality of life questionnaire. It was developed to measure the impact of Chronic Obstructive Pulmonary Disease (COPD) on a person's life. It consists of 20 items across four dimensions: dyspnea, fatigue, emotional function, and mastery. Items in each section are scored from 1 (most severe) to 7 (no impairment). Therefore total scores can range from 20 (severe impairment) to 140 (no impairment).	baseline, 20 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Roberto Benzo, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 15-007994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No