Supporting Evidence-based Responses to Emotional Needs in Emphysema
- Conditions
- COPD
- Interventions
- Behavioral: Coping Skills TrainingBehavioral: COPD Education
- Registration Number
- NCT06600126
- Lead Sponsor
- University of Pennsylvania
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
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
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coping Skills Training Coping Skills Training - COPD Education COPD Education -
- Primary Outcome Measures
Name Time Method Patient Psychological Distress Baseline, 14 weeks 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.
- Secondary Outcome Measures
Name Time Method Patient Psychological Distress (Secondary Outcome) Baseline, 7 weeks, 26 weeks 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.
Patient Anxiety Baseline, 7 weeks, 14 weeks, 26 weeks 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.
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 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.
Health-Related Quality of Life (mMRC Dyspnoea Scale) Baseline, 7 weeks, 14 weeks, 26 weeks 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.
Health-Related Quality of Life (COPD Assessment Test™) Baseline, 7 weeks, 14 weeks, 26 weeks 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.
Time to COPD-Related Hospitalization 12 months following enrollment 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.
All-Cause Mortality 12 months following enrollment 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.
Caregiver Burden Baseline, 7 weeks, 14 weeks, 26 weeks 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.
Family Relationship Quality Baseline, 5 weeks, 12 weeks, 24 weeks 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.
Self-Efficacy Baseline, 5 weeks, 12 weeks, 24 weeks 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.
Patient Loneliness Baseline, 5 weeks, 12 weeks, and 24 weeks following enrollment 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.
Caregivers' Psychological Distress Baseline, 5 weeks, 12 weeks, 24 weeks 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.
Caregiver Anxiety Baseline, 5 weeks, 12 weeks, 24 weeks 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.
Trial Locations
- Locations (2)
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States