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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 belowSelect...
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:Select...
I have severe sleep apnea that hasn't been treated.
Select...
I have major depression that hasn't been treated.
Select...
I have a history of bipolar disorder or psychosis.
Select...
I often feel extremely sleepy during the day.
Select...
I have not treated my restless legs, delayed sleep phase, or irregular sleep patterns.
Select...
I have asthma or my lung function tests show restrictive lung disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months post-pulmonary rehabilitation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months post-pulmonary rehabilitation
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
1,668 Previous Clinical Trials
3,765,770 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Insomnia Disorder.I have been in a lung rehab program in the last year.You have a high risk of wanting to harm yourself.I am eligible for a lung rehab program.You have struggled with drug or alcohol abuse in the last 3 months.I have severe sleep apnea that hasn't been treated.I have major depression that hasn't been treated.I have a history of bipolar disorder or psychosis.I have been diagnosed with COPD according to GOLD standards.My mental and physical health conditions are stable.I often feel extremely sleepy during the day.I am 40 years old or older.You have moderate to severe insomnia based on a score of 10 or more on the Insomnia Severity Index.I have not treated my restless legs, delayed sleep phase, or irregular sleep patterns.I have asthma or my lung function tests show restrictive lung disease.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Online insomnia patient education
- Group 2: Internet-based behavioral treatment for insomnia