Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation

Study Overview
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Brief Summary
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This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia during home-based pulmonary rehabilitation (HBPR) versus those only receiving HBPR. Participants will undergo a sleep and health assessment that will be performed prior to the beginning of HBPR and at the end of HBPR and 6-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia plus HBPR or HBPR only.

Detailed Description
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Veterans with chronic obstructive pulmonary disease (COPD) are a vulnerable group for developing insomnia. Pulmonary rehabilitation is a key component of COPD management, yet it does not address sleep. Comorbid insomnia may interfere with Veterans achieving maximum benefits from pulmonary rehabilitation. Implementing an insomnia-specific treatment in Veterans with COPD undergoing pulmonary rehabilitation will likely lead to improved sleep that could help improve and sustain the benefits gained from pulmonary rehabilitation. This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia during home-based pulmonary rehabilitation (HBPR) versus those only receiving HBPR. Veterans 40 years and older, who received care from the VA Pittsburgh Healthcare System, and who have COPD and insomnia will be recruited for this study. Participants will undergo a sleep and health assessment that will be performed prior to the beginning of HBPR and at the end of HBPR and 6-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia plus HBPR or HBPR only. Both the insomnia treatment and HBPR will be provided remotely.

Official Title
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Enhancing Pulmonary Rehabilitation in Veterans With Chronic Obstructive Pulmonary Disease Through Internet-based Cognitive-behavioral Treatment for Insomnia

Conditions
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Chronic Obstructive Pulmonary Disease, Insomnia

Intervention / Treatment
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* Behavioral: Internet-based behavioral treatment for insomnia + HBPR
* Behavioral: HBPR only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 years and older Primary diagnosis of COPD defined by GOLD Meets criteria for enrollment in pulmonary rehabilitation Meets criteria for Insomnia Disorder At least moderate insomnia severity based on Insomnia Severity Index score 10 Stable psychiatric and medical conditions Must have telephone, email, and reliable Internet access via computer, smartphone, or tablet Exclusion Criteria: Enrolled in pulmonary rehabilitation in the past 12 months Untreated current major depression Serious suicidal risk Substance abuse disorder within past 3 months History of bipolar or psychosis Untreated restless legs syndrome, delayed sleep phase syndrome, irregular sleep schedules Very severe untreated obstructive sleep apnea Severe excessive daytime sleepiness based on Epworth Sleepiness Scale score > 16 Restrictive lung disease (FEV1/FVC 70 and FEV1 < 80% predicted) or asthma Plans to move during the following 9 months Non-English speaking or sensory deficits

Ages Eligible for Study
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Minimum Age: 40 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
Interventional Model Description: Individuals will be assigned to either an internet-based behavioral treatment for insomnia plus home-based pulmonary rehabilitation or home-based pulmonary rehabilitation only simultaneously.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based behavioral treatment for insomnia + HBPR<br>Internet version of cognitive-behavioral treatment for insomnia plus home-based pulmonary rehabilitation | Behavioral: Internet-based behavioral treatment for insomnia + HBPR<br>* Internet version of cognitive-behavioral treatment for insomnia plus home-based pulmonary rehabilitation<br>|
| Experimental: HBPR only<br>Home-based pulmonary rehabilitation only | Behavioral: HBPR only<br>* Home-based pulmonary rehabilitation only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | The Insomnia Severity Index is a 7-item self-report questionnaire assessing nature, severity and impact of insomnia symptoms. The total score ranges from 0 to 28, with higher scores indicating worse insomnia severity. | Baseline to post-pulmonary rehabilitation and 6-months post-pulmonary rehabilitation | 
| St. George's Respiratory Questionnaire | The SGRQ is a 50-item measure assessing disease-specific quality of life. The total SGRQ score, which reflects the overall impact of the disease on quality of life, ranges from 0 to 100, with higher scores indicating greater impairment. | 6-months post-pulmonary rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Insomnia