Mindfulness to Mitigate the Effect of Anxiety-depression-fear in COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Mayo Clinic
- Locations
- 1
- Primary Endpoint
- Change in Quality of Life as measured by the Chronic Respiratory Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mindfulness
Intervention: Mindfulness (Behavioral)
Outcomes
Primary Outcomes
Change in Quality of Life as measured by the Chronic Respiratory Questionnaire
Time Frame: baseline, 20 weeks
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Roberto P. Benzo
MD
Mayo Clinic