RecruitingNot ApplicableNCT06600126

Supporting Evidence-based Responses to Emotional Needs in Emphysema

Sponsor

University of Pennsylvania

Enrollment

750 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

COPD

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 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria7

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

Interventions

BEHAVIORALCoping Skills Training

The Coping Skills Training arm will consist of 12 weekly 30-minute sessions via videoconferencing or phone. A trained research staff member will deliver sessions that focus on building coping skills for patients with COPD, such as progressive relaxation training, pleasant activity scheduling, and building communication skills. Caregivers will also participate, learning how to support the patient in using these skills. Participants will complete assignments between sessions to reinforce their learning. Additionally, participants will receive a Coping Skills Training workbook.

BEHAVIORALCOPD Education

The COPD Education arm will consist of 12 weekly 10-minute sessions via videoconferencing or phone. A trained research staff member will provide scripted general support and encouragement without using specific psychoeducational techniques. Caregivers will also participate. Additionally, participants will receive a COPD Education workbook with material from The COPD Foundation, which is also available on the Foundation's website. This program augments usual care, providing an attention control for comparison.