Supporting Evidence-based Responses to Emotional Needs in Emphysema
Recruiting · NCT06600126 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pennsylvania
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to understand how a Coping Skills Training program can reduce depression and anxiety in people with chronic obstructive pulmonary disease (COPD), particularly those who face health disparities, including those with low income, different racial backgrounds, or those living in rural areas. The main questions it aims to answer are: * How does the Coping Skills Training program help reduce stress and anxiety in patients? * What causes variations in the effectiveness of the Coping Skills Training program? * What are the barriers and facilitators to the uptake of the Coping Skills Training program? Researchers will compare a 12-week Coping Skills Training program with a COPD Education program to see if the training leads to better health outcomes for participants. Participants will: * Take part in weekly 30-minute sessions for 12 weeks if assigned to the Coping Skills Training group. * Take part in weekly 10-minute sessions for 12 weeks if assigned to the COPD Education group. * Complete surveys before, during, and after the intervention. * Patients and caregivers, including those who chose not to enroll, as well as clinicians, will be invited to participate in interviews to share their perspectives.
Who can take part
Inclusion criteria
- Patients
- Be at least 18 years of age
- Have a documented diagnosis of COPD and confirmation of obstructive lung disease by spirometry (American Thoracic Society/European Respiratory Society guidelines) or radiology (imaging report indicating emphysematous changes)
- Score greater than or equal to 8 during baseline screening using the PHQ-8
- Identify an adult caregiver to participate with them
- Have the ability to access a telephone or videoconferencing call up to once weekly (for approximately 30 minutes) for 12 sessions of the study intervention
- Spoken proficiency in Spanish and/or English
- Caregivers
- Be at least 18 years of age
- Have the ability to access a telephone or videoconferencing call up to once weekly (for approximately 30 minutes) for 12 weeks
Exclusion criteria
- Patients
- Has significant dementia or cognitive impairment
- Documentation in the EHR that the COPD diagnosis has not yet been disclosed to the patient
- Is under the ongoing care of a licensed behavioral health clinician
- Requires immediate referral to specialized behavioral health management
- Caregivers
- Has significant dementia or cognitive impairment
Where it is running
2 locations listed across 2 US states.
- Henry Ford Health System - Detroit, Michigan, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States