Supporting Evidence-based Responses to Emotional Needs in Emphysema (SERENE)

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Behavioral: Coping Skills Training; Behavioral: COPD Education

Detailed Description

Social environments, including family structure and function, shape patients' care and outcomes. Yet the role of family caregivers in chronic illness care is often unrecognized or undervalued even when critically relevant. For example, psychological distress is highly prevalent among patients with chronic obstructive pulmonary disease (COPD). COPD affects more than 212 million people worldwide, annual US medical costs are over $49 billion, and groups experiencing health disparities are most affected. Family caregivers, patients, and clinicians identify emotional symptoms and coping as critical priorities in COPD care. Psychological distress is strongly associated with poor quality of life and clinical outcomes for patients with COPD, such as more frequent exacerbations and higher post-discharge mortality. Yet affected patients rarely receive psychological care, particularly patients who face barriers to behavioral health care access. Integrating families into approaches to reduce patients' psychological distress is likely to improve outcomes and equity.

The investigators' overarching objective is to reduce the burden of chronic illness on patients and families. The central hypothesis is that improving patients' coping skills and caregivers' ability to coach patients in use of these skills will improve patients' outcomes. The existing evidence amongst patients with COPD is strongest for non- pharmacological interventions for psychological distress, but fails to represent diverse study populations. High-quality family relationships (i.e., cohesion, problem solving, and communication) are associated with better clinical outcomes. Among patients with COPD, better family relationship quality is associated with reduced psychological distress and improved self-management and dyspnea. Coping Skills Training is a scalable intervention that uses cognitive-behavioral skills to teach patient-caregiver dyads how to respond to the many emotional, physical, functional, and psychosocial consequences of COPD. In an NIH-funded trial of 326 dyads, Coping Skills Training improved patients' psychological and health-related quality of life more than an educational control. Yet, the mechanisms of the intervention's success remain unknown and the prior work underrepresented groups experiencing health disparities. Filling these critical knowledge gaps is an urgent need that will allow the investigators to refine and scale effective and efficient interventions addressing this critical need.

The investigators propose a randomized clinical trial to test putative treatment mechanisms through which the Coping Skills Training program administered to patients with COPD and their family caregivers improves outcomes. Outpatients with COPD who screen positive for psychological distress will be randomized in a 2:1 ratio to participate in a 12-week program with a caregiver, either a Coping Skills Training program (i.e., weekly 30-minute protocolized sessions delivered by a behavioral health specialist) or COPD Education program (i.e., weekly 10-minute sessions without coping skills).

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna Hart, MD, MSHP; Phone Number: 267-271-0665; Email: Joanna.Hart@pennmedicine.upenn.edu
• Study Contact Backup: Name: Daniel Carter, PhD; Phone Number: 215-573-7082; Email: Daniel.Carter@pennmedicine.upenn.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
      • Contact: Lisa Matero, PhD; Phone Number: 313-874-6677; Email: lmatero1@hfhs.org
      • Principal Investigator: Lisa Matero, PhD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Joanna Hart, MD, MSHP; Phone Number: 267-271-0665; Email: Joanna.Hart@pennmedicine.upenn.edu
      • Contact: Daniel Carter; Phone Number: 215-573-7082; Email: Daniel.Carter@pennmedicine.upenn.edu
      • Principal Investigator: Joanna Hart, MD, MSHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coping Skills Training	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.
Experimental: COPD Education	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Psychological Distress (Secondary Outcome)	Patient psychological distress will be measured as a secondary outcome using the Patient Health Questionnaire-9 (PHQ-9) after 7 weeks and 14 weeks. As described above, the PHQ-9 consists of 9 items, with total scores ranging from 0 to 27. Higher scores indicate greater distress.	Baseline, 7 weeks, 26 weeks
Patient Anxiety	Patient anxiety will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of 7 items, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety.	Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (St. George's Respiratory Questionnaire for COPD patients)	Health-related quality of life will be measured using the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C). The SGRQ-C consists of 40 items, with total scores ranging from 0 to 100. Higher scores indicate greater limitations and poorer health-related quality of life.	Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (mMRC Dyspnoea Scale)	Health-related quality of life will also be measured using the Modified Medical Research Council (mMRC) Dyspnoea Scale. The mMRC consists of 1 item, with a 5-point scale from 0 to 4. Higher scores indicate poorer health-related quality of life.	Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (COPD Assessment Test™)	Health-related quality of life will also be measured using the COPD Assessment Test™ (CAT™). The CAT consists of 8 items, with total scores ranging from 0 to 40. Higher scores indicate poorer health-related quality of life.	Baseline, 7 weeks, 14 weeks, 26 weeks
Time to COPD-Related Hospitalization	Time to COPD-related hospitalization will be assessed by reviewing electronic health records for hospitalizations occurring within the 12-month period following enrollment. Hospitalizations will be identified as COPD-related if the condition is listed as a primary or secondary diagnosis, or if the records indicate that COPD was an active or contributory condition. Time to COPD hospitalization will be measured in days from the trial enrollment date.	12 months following enrollment
All-Cause Mortality	All-cause mortality will be tracked through electronic health record reviews. Additional data will be gathered from caregivers and confirmed through Internet obituary searches, if necessary, to ensure accurate capture of deaths not recorded in medical records.	12 months following enrollment
Caregiver Burden	Caregiver burden will be measured using the Zarit Caregiver Burden Inventory (ZBI). The ZBI consists of 22 items, with total scores ranging from 0 to 88. Higher scores indicate greater burden.	Baseline, 7 weeks, 14 weeks, 26 weeks
Family Relationship Quality	Family relationship quality will be measured using the Family Emotional Involvement and Criticism Scale (FEICS). The FEICS consists of 14 items with 2 subscales (perceived criticism and emotional involvement), each with total scores ranging from 0 to 28. Higher scores indicate more expressed emotion in family relationships.	Baseline, 5 weeks, 12 weeks, 24 weeks
Self-Efficacy	Self-efficacy will be measured among patients and caregivers using the General Self-Efficacy Scale (GSE). The GSE consists of 10 items, with total scores ranging from 10 to 40. Higher scores indicate greater self-efficacy.	Baseline, 5 weeks, 12 weeks, 24 weeks
Patient Loneliness	Patient-reported loneliness will be measured using the UCLA Loneliness Scale. The UCLA Loneliness Scale consists of 20 items, with total scores ranging from 20 to 80. Lower scores indicate greater feelings of loneliness.	Baseline, 5 weeks, 12 weeks, and 24 weeks following enrollment
Caregivers' Psychological Distress	Caregivers' psychological distress will be measured using the PHQ-9. As described above, the PHQ-9 consists of 9 items, with total scores ranging from 0 to 27. Higher scores indicate greater distress.	Baseline, 5 weeks, 12 weeks, 24 weeks
Caregiver Anxiety	Caregivers' anxiety will be measured using the Generalized Anxiety Disorder-7 (GAD-7). As described above, the GAD-7 consists of 7 items, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety.	Baseline, 5 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Nursing Research (NINR); Henry Ford Health System; Thomas Jefferson University
• Investigators: Principal Investigator: Joanna Hart, MD, MSHP, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 5, 2028

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Psychological Distress; Mixed Methods; Coping Skills; Pulmonary Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 852619; R01NR020819 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Three datasets will be generated: (1) survey data from participants (patients and caregivers), (2) electronic health record data from patient participants, and (3) interview data from patients, caregivers, and clinicians. These datasets will be shared through the Inter-university Consortium for Political and Social Research (ICPSR) data repository. The shared data will be de-identified according to ICPSR's de-identification standards.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No