Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-27 @ 12:42 AM
Study NCT ID:
NCT01072292
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2010-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Nurse Managed Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A two-phase research study is being conducted. In Phase 1 of the study, the cognitive behavioral therapy intervention for insomnia was implemented in a small (n = 5) group of people with moderate to severe COPD and insomnia. The intervention was pilot-tested to determine feasibility and acceptability, and the intervention will be refined as needed. In Phase 2 of the study, a two-group randomized controlled study (n = 20) will be conducted to test the effects of the cognitive behavioral therapy for insomnia intervention on the primary outcomes of sleep quality and fatigue and the secondary outcomes of mood and functional performance. It is hypothesized that people with COPD receiving cognitive behavioral therapy for insomnia will demonstrate significant improvements in sleep quality, fatigue, mood and functional performance as compared to people with COPD who receive a wellness program. This research will yield valuable information regarding effective interventions aimed at mitigating problems such as poor sleep quality, fatigue and reduced ability to perform valued daily activities. This information will be used to increase the likelihood of long-term successful outcomes such as the ability to maintain productive roles in society for people with COPD.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: