A Behavioral Therapy for Insomnia Co-existing With COPD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD

Conditions
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Insomnia, COPD, Chronic Obstructive Pulmonary Disease, Fatigue

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia
* Behavioral: COPD Education
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy (CBT-I)<br>Six weekly sessions of Cognitive Behavioral Therapy for Insomnia | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* Six weekly sessions of cognitive behavioral therapy for insomnia<br>|
| Experimental: CBT-I + COPD-ED<br>Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* Six weekly sessions of cognitive behavioral therapy for insomnia<br>Behavioral: COPD Education<br>* Six weekly sessions of COPD education<br>|
| Experimental: COPD Education (COPD-ED)<br>Six weekly sessions of COPD education | Behavioral: COPD Education<br>* Six weekly sessions of COPD education<br>|
| Placebo Comparator: Attention Control (AC)<br>Six weekly sessions of non-sleep, non-COPD health education | Behavioral: Attention Control<br>* Six weekly sessions of non-sleep, non-COPD health education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia | Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire. | Up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Change in the level of fatigue will be assessed using the Chronic Respiratory Disease Questionnaire Fatigue scale and the PROMIS Fatigue scale. | Up to 18 weeks | 
| Beliefs about sleep | Change in beliefs about sleep will be measured using the DBAS questionnaire | Up to 18 weeks | 
| Sleep habits | Change in sleep habits will be measured using a Sleep Diary and Actigraphy | Up to 18 weeks | 
| Self-efficacy for sleep | Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale | Up to 18 weeks | 
| Self-efficacy for COPD management | Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale. | Up to 18 weeks | 
| Emotional arousal | Change in emotional arousal will be measured using the PROMIS anxiety and depression scales | Up to 18 weeks | 
| Inflammation | Change in inflammation will be measured using C-reactive protein. | 6 weeks | 
| Pulmonary function | Change in pulmonary function will be measured using pulmonary function tests. | 6 weeks | 
| Daytime functioning | Change in daytime functioning will be measured using actigraphy, the Chronic Respiratory Disease Questionnaire Dyspnea Scale and the PROMIS Physical Functioning Scale. | Up to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, cognitive behavioral therapy, COPD, fatigue