Supporting Evidence-based Responses to Emotional Needs in Emphysema

NCT06600126 | Recruiting

• 2 other identifiers: 852619R01NR020819
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 2

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

Keywords

Pulmonary Disease; Coping Skills; Psychological Distress; Mixed Methods

Outcome Measures

Primary Outcomes (1)

• Patient Psychological Distress

  Patient psychological distress will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, with total scores ranging from 0 to 27. Higher scores indicate greater distress.

  Baseline, 14 weeks

Secondary Outcomes (13)

• Patient Psychological Distress (Secondary Outcome)

  Baseline, 7 weeks, 26 weeks

• Patient Anxiety

  Baseline, 7 weeks, 14 weeks, 26 weeks

• Health-Related Quality of Life (St. George's Respiratory Questionnaire for COPD patients)

  Baseline, 7 weeks, 14 weeks, 26 weeks

• Health-Related Quality of Life (mMRC Dyspnoea Scale)

  Baseline, 7 weeks, 14 weeks, 26 weeks

• Health-Related Quality of Life (COPD Assessment Test™)

  Baseline, 7 weeks, 14 weeks, 26 weeks

Study Arms (2)

Coping Skills Training

EXPERIMENTAL

Behavioral: Coping Skills Training

COPD Education

EXPERIMENTAL

Behavioral: COPD Education

Interventions

Coping Skills Training BEHAVIORAL

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.

Coping Skills Training

COPD Education BEHAVIORAL

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.

COPD Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Nursing Research (NINR): collaborator
• Henry Ford Health System: collaborator
• Thomas Jefferson University: collaborator

Study Sites (2)

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• Hart JL, Carter D, Hinton C, Grilli J, Brown LA, Brier N, Lu Y, Whitman C, Harhay MO, Sims M, Alvarez C, Miller-Matero LR, O'Hayer CV. Supporting Evidence-based Responses to Emotional Needs in Emphysema (SERENE): protocol for a randomized, open-label mechanistic trial comparing Coping Skills Training and disease-specific education for depressive symptoms conducted in United States health systems. Trials. 2026 Feb 25;27(1):262. doi: 10.1186/s13063-025-09210-0.

  PMID: 41742282 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joanna Hart, MD, MSHP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna Hart, MD, MSHP

CONTACT

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

Daniel Carter, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 5, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be made available as soon as possible or at the time of manuscript publication. The ICPSR allows for datasets to be archived and preserved on its servers indefinitely.
• Access Criteria: Dataset A will be made available for public use via direct download from ICPSR, where usage will be free of charge to other ICPSR member institutions. Users who download the data are required to comply with ICPSR's Responsible Use Policy and must receive permission from ICPSR prior to re-distribution. Dependent on the stipulations of the data use agreements with HFHS, the investigators will enter into a restricted use agreement with ICPSR for resharing Dataset B under data use agreements and IRB permissions for the requestors. The investigators will be guided by ICPSR curators and the Penn IRB as to their assessment of the disclosure risk of Dataset C - even after deidentification of individual transcripts - to see if restricted use agreements are recommended.

Locations

US (2)