Clinical trial NCT04700098: Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
Official title: Enhancing Pulmonary Rehabilitation in Veterans With Chronic Obstructive Pulmonary Disease Through Internet-based Cognitive-behavioral Treatment for Insomnia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Insomnia
Keywords: Chronic Obstructive Pulmonary Disease
Insomnia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-01-07
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals will be assigned to either an internet-based behavioral treatment for insomnia or online insomnia patient education.
Primary purpose: TREATMENT

Brief summary: 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 versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.

Detailed description: Veterans with chronic obstructive pulmonary disease (COPD) are a vulnerable group for developing insomnia. Insomnia has been found to be associated with limitations in activities of daily living (ADL), lower physical activity levels, poor quality of life, greater COPD symptom severity, and reduced exercise performance. Cognitive-behavioral therapy for insomnia (CBT-I) is an efficacious and durable non-pharmacological treatment for insomnia that provides guidance on changing unhealthy sleep-related beliefs and behaviors across a variety of illnesses. CBT-I not only improves sleep-specific symptoms of insomnia but also improves quality of life and daytime function, reduces ADL limitations, and improves condition-specific symptoms.

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 versus online insomnia patient education. 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 at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education. Both the insomnia treatment and patient education will be provided remotely.

Eligibility criteria: Inclusion Criteria:

* Age 40 years and older
* Primary diagnosis of COPD defined by GOLD
* Meets criteria for Insomnia Disorder
* At least moderate insomnia severity based on Insomnia Severity Index score \>7
* Stable psychiatric and medical conditions
* Must have telephone, email, and reliable Internet access via computer, smartphone, or tablet

Exclusion Criteria:

* 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 6 months
* Non-English speaking or sensory deficits

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline to post-treatment and 3-months post-treatment
measure: St. George's Respiratory Questionnaire
timeFrame: 6-months post-pulmonary rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit, MI
state: Michigan
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Faith S Luyster, PhD
role: PRINCIPAL_INVESTIGATOR
References: