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

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT01072292

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: CBT-I	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Nurse Managed Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

sleep quality [6-8 weeks]

Secondary Outcome Measures

fatigue/tiredness, using the Chronic Respiratory Disease Questionnaire [6-8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mary C. Kapella, Assistant Professor, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT01072292

Other Study ID Numbers:

KO1 NR010749

First Posted:

Feb 22, 2010

Last Update Posted:

Jun 3, 2014

Last Verified:

Jun 1, 2014

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jun 3, 2014