Supporting Evidence-based Responses to Emotional Needs in Emphysema

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.

Conditions

• COPD

Interventions

BEHAVIORAL

Coping 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.

BEHAVIORAL

COPD 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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Henry Ford Health System

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Joanna Hart, MD, MSHP · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-30

Primary Completion

2027-06-01

Completion

2028-03-05

Countries

• United States

Study Locations