View Clinical Trial (Medical Research Study)
Nurse Managed Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60612 |
| Conditions: |
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Insomnia |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01072292 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60612
United States
Mary C Kapella, PhD
Phone: 312-355-3150
Email: mkapel1@uic.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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