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Completed

NCT Number: NCT04700098

Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing 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 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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John D. Dingell VA Medical Center, Detroit, MI, Detroit, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based behavioral treatment for insomnia

Behavioral

Internet version of cognitive-behavioral treatment for insomnia

Online insomnia patient education

Behavioral

Online insomnia patient education

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline to 3-months post-treatment

    The ISI 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.

  2. St. George's Respiratory Questionnaire (SGRQ)

    Time frame: Baseline to 3-months post-treatment

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2021
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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