Supporting Evidence-based Responses to Emotional Needs in Emphysema
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a 12-week Coping Skills Training program reduces depression and anxiety more than a COPD Education program. It is for adults with COPD, a lung disease that makes breathing hard, and symptoms of depression. The study focuses on people who face gaps in health care, including people with low income, people from different racial backgrounds, and people in rural areas.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients must be age 18 or older.
- Patients must have a recorded COPD diagnosis, confirmed by a breathing test or lung images showing emphysema.
- Patients must score 8 or higher on the PHQ-8, a survey about depression symptoms.
- Patients must name an adult caregiver who will take part with them.
- Patients must be able to join phone or video calls about 30 minutes long, up to once a week for 12 sessions.
- Patients must speak English, Spanish, or both.
- Caregivers must be age 18 or older.
- Caregivers must be able to join phone or video calls about 30 minutes long, up to once a week for 12 weeks.
Who can't join
- Patients and caregivers cannot have serious problems with memory or thinking, including dementia.
- Patients cannot have a medical record stating they have not yet been told about their COPD diagnosis.
- Patients cannot be receiving ongoing care from a licensed mental health professional.
- Patients cannot need an immediate referral for specialized mental health care.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (2)
MI
- Henry Ford Health System · Detroit, MI 48202Lisa Matero, PhD · Study contact · 313-874-6677 · lmatero1@hfhs.orgLisa Matero, PhD · Principal investigatorMore trials in Detroit
PA
- University of Pennsylvania · Philadelphia, PA 19104Joanna Hart, MD, MSHP · Study contact · 267-271-0665 · Joanna.Hart@pennmedicine.upenn.eduDaniel Carter · Study contact · 215-573-7082 · Daniel.Carter@pennmedicine.upenn.eduJoanna Hart, MD, MSHP · Principal investigatorMore trials in Philadelphia