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Coping Skills Training for COPD (SERENE Trial)
N/A
Recruiting
Led By Joanna Hart, MD, MSHP
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a documented diagnosis of COPD and confirmation of obstructive lung disease by spirometry or radiology
Patients must be at least 18 years of age
Must not have
Patients requiring immediate referral to specialized behavioral health management
Patients with significant dementia or cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following enrollment
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if a Coping Skills Training program can help reduce depression and anxiety in people with chronic obstructive pulmonary disease (COPD), especially those facing health disparities. They want to
Who is the study for?
This trial is for people with COPD, especially emphysema, who may be dealing with depression and anxiety. It's focused on helping those facing health disparities such as low income, different racial backgrounds, or living in rural areas.
What is being tested?
The study compares a Coping Skills Training program (12 weekly sessions of 30 minutes) against a COPD Education program (12 weekly sessions of 10 minutes) to see which better improves mental health outcomes in participants.
What are the potential side effects?
Since the interventions involve educational and coping skills training programs rather than medications, there are no direct physical side effects expected from participating in this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with COPD and my lung obstruction is confirmed by tests.
Select...
I am at least 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need to be referred to a specialist for my mental health.
Select...
I have significant memory or thinking problems.
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My caregiver does not have significant dementia or cognitive issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months following enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient Psychological Distress
Secondary study objectives
All-Cause Mortality
Caregiver Anxiety
Caregiver Burden
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Coping Skills TrainingExperimental Treatment1 Intervention
Group II: COPD EducationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
COPD Education
2014
N/A
~110
Coping Skills Training
2008
Completed Phase 3
~470
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,298 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
465 Previous Clinical Trials
176,103 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,377,966 Total Patients Enrolled
Henry Ford Health SystemOTHER
311 Previous Clinical Trials
2,175,643 Total Patients Enrolled
Joanna Hart, MD, MSHPPrincipal InvestigatorUniversity of Pennsylvania