Status:
RECRUITING
Supporting Evidence-based Responses to Emotional Needs in Emphysema
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Henry Ford Health System
Conditions:
COPD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Social environments, including family structure and function, shape patients' care and outcomes. Yet the role of family caregivers in chronic illness care is often unrecognized or undervalued even whe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 5 2028
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06600126
Start Date
September 30 2024
End Date
March 5 2028
Last Update
May 13 2025
Active Locations (2)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104