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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a counselling program designed to help patients with COPD (a chronic lung disease) and their caregivers manage the emotional and mental health challenges that often come with the illness, such as depression and anxiety. **You may be eligible if...** - You are 18 or older - You have been diagnosed with COPD, confirmed by breathing tests or imaging showing emphysema - You scored 8 or higher on a depression screening questionnaire (PHQ-8) - You have an adult caregiver who agrees to participate with you - You are able to attend weekly phone or video calls (about 30 minutes each) for 12 sessions - You speak Spanish and/or English - (Caregivers must also be 18 or older and able to attend the calls) **You may NOT be eligible if...** - You have significant dementia or cognitive impairment - Your COPD diagnosis has not yet been disclosed to you by your medical team - You are already seeing a mental health professional (licensed therapist, psychologist, etc.) - You need immediate referral for urgent mental health care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(2)

Henry Ford Health System

Detroit, Michigan, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06600126


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