Clinical trial NCT06600126: Supporting Evidence-based Responses to Emotional Needs in Emphysema
Official title: Supporting Evidence-based Responses to Emotional Needs in Emphysema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Keywords: Pulmonary Disease
Coping Skills
Psychological Distress
Mixed Methods
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Henry Ford Health System
name: Thomas Jefferson University
First posted: 2024-09-19
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Psychological Distress
timeFrame: Baseline, 14 weeks
Secondary outcomes:
measure: Patient Psychological Distress (Secondary Outcome)
timeFrame: Baseline, 7 weeks, 26 weeks
measure: Patient Anxiety
timeFrame: Baseline, 7 weeks, 14 weeks, 26 weeks
measure: Health-Related Quality of Life (St. George's Respiratory Questionnaire for COPD patients)
timeFrame: Baseline, 7 weeks, 14 weeks, 26 weeks
measure: Health-Related Quality of Life (mMRC Dyspnoea Scale)
timeFrame: Baseline, 7 weeks, 14 weeks, 26 weeks
measure: Health-Related Quality of Life (COPD Assessment Test™)
timeFrame: Baseline, 7 weeks, 14 weeks, 26 weeks
measure: Time to COPD-Related Hospitalization
timeFrame: 12 months following enrollment
measure: All-Cause Mortality
timeFrame: 12 months following enrollment
measure: Caregiver Burden
timeFrame: Baseline, 7 weeks, 14 weeks, 26 weeks
measure: Family Relationship Quality
timeFrame: Baseline, 5 weeks, 12 weeks, 24 weeks
measure: Self-Efficacy
timeFrame: Baseline, 5 weeks, 12 weeks, 24 weeks
measure: Patient Loneliness
timeFrame: Baseline, 5 weeks, 12 weeks, and 24 weeks following enrollment
measure: Caregivers' Psychological Distress
timeFrame: Baseline, 5 weeks, 12 weeks, 24 weeks
measure: Caregiver Anxiety
timeFrame: Baseline, 5 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Joanna Hart, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: