Ignite Creation Date:
2024-05-06 @ 2:06 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01973647
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2013-10-22
Brief Title:
A Behavioral Therapy for Insomnia Co-existing With COPD
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD
Status:
COMPLETED
Status Verified Date:
2019-09
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:
Difficulty falling asleep staying asleep or poor quality sleep insomnia is common in people with chronic obstructive pulmonary disease Insomnia is related to greater mortality with four times the risk of mortality for sleep times 300 minutes Insomnia is also related to greater morbidity with 75 greater health care costs than people without insomnia However insomnia medications are used with caution in COPD due to potential adverse effects Common features of COPD such as dyspnea chronic inflammation anxiety and depression also affect insomnia and can interfere with therapy outcomes While cognitive behavioral therapy for insomnia CBT-I a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior is effective for people with primary insomnia and people with other chronic illnesses the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education COPD-ED - in people with coexisting insomnia and COPD and to identify mechanisms responsible for therapy outcomes The central hypothesis is that both CBT-I and COPD-ED will have positive lasting effects on objectively and subjectively measured insomnia and fatigue The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known new and innovative approaches for insomnia coexisting with COPD can be developed thereby leading to longer higher quality and more productive lives for people with COPD and reduced societal cost due to the effects of insomnia The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I COPD-ED and non-COPD non-sleep health education attention control AC using a highly efficient 4-group design Arm 1 comprises 6 weekly sessions of CBT-IAC Arm 26 sessions of COPD-EDAC Arm 3CBT-ICOPD-ED and Arm 4AC This design will allow completion of the following Specific Aims 1 Determine the efficacy of individual treatment components CBT-I and COPD-ED on insomnia and fatigue 2 Define mechanistic contributors to the outcomes after CBT-I and COPD-ED The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy namely by testing traditional CBT-I with education to enhance outcomes
Detailed Description:
The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I COPD-ED and non-COPD non-sleep health education attention control AC using a highly efficient 4-group design Arm 1 comprises 6 weekly sessions of CBT-IAC Arm 26 sessions of COPD-EDAC Arm 3CBT-ICOPD-ED and Arm 4AC This design will allow completion of the following Specific Aims 1 Determine the efficacy of individual treatment components CBT-I and COPD-ED on insomnia and fatigue 2 Define mechanistic contributors to the outcomes after CBT-I and COPD-ED
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