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

Last updated: July 14, 2025
Sponsor: VA Office of Research and Development
Overall Status: Completed

Phase

N/A

Condition

Insomnia

Treatment

Online insomnia patient education

Internet-based behavioral treatment for insomnia

Clinical Study ID

NCT04700098
F3513-R
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 sleepschedules

  • 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

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Online insomnia patient education
Phase:
Study Start date:
February 14, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • John D. Dingell VA Medical Center, Detroit, MI

    Detroit, Michigan 48201-1916
    United States

    Site Not Available

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

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