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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03385317
• Other study ID #: 15-007994
• Status: Withdrawn
• Phase: N/A
• First received: March 17, 2016
• Last updated: December 20, 2017
• Start date: April 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: December 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Depression
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Mindfulness

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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