← Back to Search

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
Meets criteria for enrollment in pulmonary rehabilitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months post-pulmonary rehabilitation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with Insomnia Disorder.
Select...
I am eligible for a lung rehab program.
Select...
I have been diagnosed with COPD according to GOLD standards.
Select...
My mental and physical health conditions are stable.
Select...
I am 40 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index
St. George's Respiratory Questionnaire

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
1,606 Previous Clinical Trials
3,305,909 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: Internet-based behavioral treatment for insomnia, Online insomnia patient education

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any volunteers presently being taken for this research experiment?

"Clinicaltrials.gov confirms that this clinical study is actively enrolling participants, with the initial posting having been published on February 14th 2022 and most recently revised on March 7th 2022."

Answered by AI

How many participants are actively taking part in the experiment?

"Affirmative, clinicaltrials.gov data suggests that this medical research is actively looking for volunteers. This project was initiated on February 14th 2022 and has been edited as recently as March 7th of the same year. 125 participants must be secured from a single site to complete the trial."

Answered by AI
~16 spots leftby Sep 2024