Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600126
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Supporting Evidence-based Responses to Emotional Needs in Emphysema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Supporting Evidence-based Responses to Emotional Needs in Emphysema
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERENE
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
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 ie 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 interventions 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 21 ratio to participate in a 12-week program with a caregiver either a Coping Skills Training program ie weekly 30-minute protocolized sessions delivered by a behavioral health specialist or COPD Education program ie weekly 10-minute sessions without coping skills
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 ie 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 interventions 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 21 ratio to participate in a 12-week program with a caregiver either a Coping Skills Training program ie weekly 30-minute protocolized sessions delivered by a behavioral health specialist or COPD Education program ie weekly 10-minute sessions without coping skills
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None