Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT06600126

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coping Skills Training

COPD Education

Study Details

Brief 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

Study ID

NCT06600126

Start date

Sep 30, 2024

Status verified date

Jan, 2026

Completion date

Mar 5, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Coping Skills Training

experimental: COPD Education

Interventions

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.

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.

Primary outcome measure

  • Patient Psychological Distress [ Time Frame: Baseline, 14 weeks ]

Central Contacts and Locations

Central contacts

Joanna Hart, MD, MSHP

267-271-0665Joanna.Hart@pennmedicine.upenn.edu

Daniel Carter, PhD

215-573-7082Daniel.Carter@pennmedicine.upenn.edu

Locations

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Lisa Matero, PhD

313-874-6677lmatero1@hfhs.org

Principal Investigator:

Lisa Matero, PhD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Joanna Hart, MD, MSHP

267-271-0665Joanna.Hart@pennmedicine.upenn.edu

Daniel Carter

215-573-7082Daniel.Carter@pennmedicine.upenn.edu

Principal Investigator:

Joanna Hart, MD, MSHP

More Information

Sponsor

University of Pennsylvania

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Pulmonary Disease
  • Coping Skills
  • Psychological Distress
  • Mixed Methods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-01-30.