Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Insomnia |
Behavioral: cognitive behavioral therapy for insomnia (CBT-I) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Nurse Managed Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease |
- sleep quality [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
- fatigue/tiredness, using the Chronic Respiratory Disease Questionnaire [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
-
Behavioral: cognitive behavioral therapy for insomnia (CBT-I)
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Illinois | |
| University of Illinois at Chicago | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Mary C Kapella, PhD 312-355-3150 mkapel1@uic.edu | |
| Principal Investigator: Mary C Kapella, PhD | |
More Information
No publications provided
| Responsible Party: | Mary C. Kapella PhD, University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT01072292 History of Changes |
| Other Study ID Numbers: | KO1 NR010749 |
| Study First Received: | February 18, 2010 |
| Last Updated: | February 19, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Sleep Initiation and Maintenance Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013