NCT06600126 · University of Pennsylvania
Supporting Evidence-based Responses to Emotional Needs in Emphysema
(SERENE)
What this study 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- Detroit, Michigan
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations