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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2025-06-30

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 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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Individuals will be assigned to either an internet-based behavioral treatment for insomnia or online insomnia patient education.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessor will be blinded to group assignment.

Study Groups

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Internet-based behavioral treatment for insomnia

Internet version of cognitive-behavioral treatment for insomnia

Group Type EXPERIMENTAL

Internet-based behavioral treatment for insomnia

Intervention Type BEHAVIORAL

Internet version of cognitive-behavioral treatment for insomnia

Online insomnia patient education

Group Type EXPERIMENTAL

Online insomnia patient education

Intervention Type BEHAVIORAL

Online insomnia patient education

Interventions

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Internet-based behavioral treatment for insomnia

Internet version of cognitive-behavioral treatment for insomnia

Intervention Type BEHAVIORAL

Online insomnia patient education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No