Back to resultsCognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria:
- Subjects will have moderate to severe COPD. Severity of COPD will be defined according to the new GOLD standards (moderate IIA (moderate), 50% < FEV1 < 80% predicted; moderate IIB (severe) 30% < FEV1 < 50%). 58
- Insomnia. Insomnia will be defined as difficulty initiating or maintaining sleep, waking up too early or poor quality sleep. 59
- Subjects must be > 45 years of age with no other major health problems
- Subjects must be clinically stable at the time of enrollment into the study without major exacerbation of COPD within the previous two months.
Exclusion Criteria:
- Evidence of restrictive lung disease or asthma.
- Evidence of a major sleep disorder other than insomnia (sleep apnea evidenced by apnea/hypopnea index of > 10, periodic limb movement disorder, narcolepsy).
- Hypnotic, sedative, anxiolytic or antidepressant use.
- Pulse oximetry (SaO2) reading of < 90% at rest.
- Pulse oximetry (SaO2) reading of < 85% at night for > 5 minutes.
- Significant sleep apnea (apnea/hypopnea index ≥ 10).
- .Acute respiratory infection within the previous 2 months.
- Class > 2 functional status according to the New York Heart Association.
- The presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
- A self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of > 11.
- Currently participating in pulmonary rehabilitation.
Sites / Locations
- University of Illinois at Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT-I
Wellness Education
Arm Description
CBT-I
Wellness Education
Outcomes
Primary Outcome Measures
sleep quality
Secondary Outcome Measures
fatigue/tiredness, using the Chronic Respiratory Disease Questionnaire
Full Information
NCT ID
NCT01072292
First Posted
February 18, 2010
Last Updated
June 1, 2014
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01072292
Brief Title
Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)
Official Title
Nurse Managed Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-I
Arm Type
Experimental
Arm Description
CBT-I
Arm Title
Wellness Education
Arm Type
Active Comparator
Arm Description
Wellness Education
Intervention Type
Behavioral
Intervention Name(s)
CBT-I
Intervention Description
CBT-I is a six week program designed to improve sleep quality in people with COPD.
Primary Outcome Measure Information:
Title
sleep quality
Time Frame
6-8 weeks
Secondary Outcome Measure Information:
Title
fatigue/tiredness, using the Chronic Respiratory Disease Questionnaire
Time Frame
6-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will have moderate to severe COPD. Severity of COPD will be defined according to the new GOLD standards (moderate IIA (moderate), 50% < FEV1 < 80% predicted; moderate IIB (severe) 30% < FEV1 < 50%). 58
Insomnia. Insomnia will be defined as difficulty initiating or maintaining sleep, waking up too early or poor quality sleep. 59
Subjects must be > 45 years of age with no other major health problems
Subjects must be clinically stable at the time of enrollment into the study without major exacerbation of COPD within the previous two months.
Exclusion Criteria:
Evidence of restrictive lung disease or asthma.
Evidence of a major sleep disorder other than insomnia (sleep apnea evidenced by apnea/hypopnea index of > 10, periodic limb movement disorder, narcolepsy).
Hypnotic, sedative, anxiolytic or antidepressant use.
Pulse oximetry (SaO2) reading of < 90% at rest.
Pulse oximetry (SaO2) reading of < 85% at night for > 5 minutes.
Significant sleep apnea (apnea/hypopnea index ≥ 10).
.Acute respiratory infection within the previous 2 months.
Class > 2 functional status according to the New York Heart Association.
The presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
A self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of > 11.
Currently participating in pulmonary rehabilitation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary C Kapella, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22162648
Citation
Kapella MC, Herdegen JJ, Perlis ML, Shaver JL, Larson JL, Law JA, Carley DW. Cognitive behavioral therapy for insomnia comorbid with COPD is feasible with preliminary evidence of positive sleep and fatigue effects. Int J Chron Obstruct Pulmon Dis. 2011;6:625-35. doi: 10.2147/COPD.S24858. Epub 2011 Nov 24.
Results Reference
result
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Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)
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