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A Behavioral Therapy for Insomnia Co-existing With COPD

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ClinicalTrials.gov Identifier: NCT01973647
Recruitment Status : Active, not recruiting
First Posted : October 31, 2013
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mary C. Kapella, University of Illinois at Chicago

Brief Summary:
Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times < 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.

Condition or disease Intervention/treatment Phase
Insomnia COPD Chronic Obstructive Pulmonary Disease Fatigue Behavioral: Cognitive Behavioral Therapy for Insomnia Behavioral: COPD Education Behavioral: Attention Control Not Applicable

Detailed Description:
The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD
Study Start Date : June 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy (CBT-I)
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia
Six weekly sessions of cognitive behavioral therapy for insomnia

Experimental: CBT-I + COPD-ED
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education
Behavioral: Cognitive Behavioral Therapy for Insomnia
Six weekly sessions of cognitive behavioral therapy for insomnia

Behavioral: COPD Education
Six weekly sessions of COPD education

Experimental: COPD Education (COPD-ED)
Six weekly sessions of COPD education
Behavioral: COPD Education
Six weekly sessions of COPD education

Placebo Comparator: Attention Control (AC)
Six weekly sessions of non-sleep, non-COPD health education
Behavioral: Attention Control
Six weekly sessions of non-sleep, non-COPD health education




Primary Outcome Measures :
  1. Insomnia [ Time Frame: Up to 18 weeks ]
    Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: Up to 18 weeks ]
    Change in the level of fatigue will be assessed using the Chronic Respiratory Disease Questionnaire Fatigue scale and the PROMIS Fatigue scale.

  2. Beliefs about sleep [ Time Frame: Up to 18 weeks ]
    Change in beliefs about sleep will be measured using the DBAS questionnaire

  3. Sleep habits [ Time Frame: Up to 18 weeks ]
    Change in sleep habits will be measured using a Sleep Diary and Actigraphy

  4. Self-efficacy for sleep [ Time Frame: Up to 18 weeks ]
    Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale

  5. Self-efficacy for COPD management [ Time Frame: Up to 18 weeks ]
    Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale.

  6. Emotional arousal [ Time Frame: Up to 18 weeks ]
    Change in emotional arousal will be measured using the PROMIS anxiety and depression scales

  7. Inflammation [ Time Frame: 6 weeks ]
    Change in inflammation will be measured using C-reactive protein.

  8. Pulmonary function [ Time Frame: 6 weeks ]
    Change in pulmonary function will be measured using pulmonary function tests.

  9. Daytime functioning [ Time Frame: Up to 18 weeks ]
    Change in daytime functioning will be measured using actigraphy, the Chronic Respiratory Disease Questionnaire Dyspnea Scale and the PROMIS Physical Functioning Scale.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild to very severe COPD.
  • age ≥ 45 years of age with no other major healthproblems.
  • clinically stable at the time of enrollment into the study.
  • insomnia.

Exclusion criteria:

  • evidence of restrictive lung disease or asthma.
  • pulse oximetry reading of < 90% at rest or < 85% at night for > 5 min.
  • evidence of a major sleep disorder other than insomnia.
  • hypnotic use.
  • acute respiratory infection within the previous 2 months.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973647


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mary C. Kapella, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01973647     History of Changes
Other Study ID Numbers: 1R01NR013937-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

Keywords provided by Mary C. Kapella, University of Illinois at Chicago:
insomnia
cognitive behavioral therapy
COPD
fatigue

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Fatigue
Sleep Initiation and Maintenance Disorders
Respiratory Tract Diseases
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders