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Internet-Based Cognitive Behavioral Therapy for COPD with Insomnia

N/A
Recruiting
Led By Faith S Luyster, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets criteria for Insomnia Disorder
Primary diagnosis of COPD defined by GOLD
Must not have
Very severe untreated obstructive sleep apnea
Untreated current major depression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months post-pulmonary rehabilitation
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the sleep and health of veterans with COPD and insomnia who receive internet-based behavioral treatment for insomnia during home-based pulmonary rehabilitation, versus those who only receive rehabilitation.

Who is the study for?
This trial is for Veterans aged 40+ with COPD and moderate to severe insomnia, who have stable health conditions, access to the internet, and haven't been in pulmonary rehab recently. It's not for those with certain sleep disorders, very severe sleep apnea, extreme daytime sleepiness, restrictive lung diseases like asthma or plans to move soon.
What is being tested?
The study tests if adding an Internet-based treatment for insomnia to home-based pulmonary rehabilitation (HBPR) helps improve sleep and health more than HBPR alone. Participants will be randomly placed into two groups: one receiving both treatments and the other only HBPR.
What are the potential side effects?
Since this trial involves behavioral therapy via the internet rather than medication, side effects are minimal but may include discomfort from discussing personal issues or temporary increases in anxiety as new skills are learned.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Insomnia Disorder.
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I have been diagnosed with COPD according to GOLD standards.
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe sleep apnea that hasn't been treated.
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I have major depression that hasn't been treated.
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I have a history of bipolar disorder or psychosis.
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I often feel extremely sleepy during the day.
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I have not treated my restless legs, delayed sleep phase, or irregular sleep patterns.
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I have asthma or my lung function tests show restrictive lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months post-pulmonary rehabilitation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post-pulmonary rehabilitation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insomnia Severity Index
St. George's Respiratory Questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Online insomnia patient educationExperimental Treatment1 Intervention
Online insomnia patient education
Group II: Internet-based behavioral treatment for insomniaExperimental Treatment1 Intervention
Internet version of cognitive-behavioral treatment for insomnia

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,501 Total Patients Enrolled
Faith S Luyster, PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
2 Previous Clinical Trials
83 Total Patients Enrolled

Media Library

HBPR only Clinical Trial Eligibility Overview. Trial Name: NCT04700098 — N/A
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: HBPR only Highlights & Side Effects. Trial Name: NCT04700098 — N/A
HBPR only 2023 Treatment Timeline for Medical Study. Trial Name: NCT04700098 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: Online insomnia patient education, Internet-based behavioral treatment for insomnia
~10 spots leftby Mar 2025
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