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

NCT03385317 | Withdrawn

• 1 other identifier: 15-007994
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Mindfulness

EXPERIMENTAL

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

Mindfulness

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?")

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Roberto Benzo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: December 28, 2017
• Study Start: April 1, 2016
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: December 28, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)