Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary C. Kapella, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01072292
First received: February 18, 2010
Last updated: June 1, 2014
Last verified: June 2014
  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: 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

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • sleep quality [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fatigue/tiredness, using the Chronic Respiratory Disease Questionnaire [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-I
CBT-I
Behavioral: CBT-I
CBT-I is a six week program designed to improve sleep quality in people with COPD.
Active Comparator: Wellness Education
Wellness Education
Behavioral: CBT-I
CBT-I is a six week program designed to improve sleep quality in people with COPD.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072292

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Mary C Kapella, PhD University of Illinois at Chicago
  More Information

Publications:
Responsible Party: Mary C. Kapella, Assistant Professor, 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: June 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014