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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04700098
Other study ID # F3513-R
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 14, 2022
Est. completion date March 31, 2025

Study information

Verified date January 2024
Source VA Office of Research and Development
Contact Faith S Luyster, PhD
Phone (412) 360-2854
Email Faith.Luyster@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date March 31, 2025
Est. primary completion date September 2, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Internet-based behavioral treatment for insomnia
Internet version of cognitive-behavioral treatment for insomnia
Online insomnia patient education
Online insomnia patient education

Locations

Country Name City State
United States John D. Dingell VA Medical Center, Detroit, MI Detroit Michigan
United States VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insomnia Severity Index The Insomnia Severity Index 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. Baseline to post-treatment and 3-months post-treatment
Primary St. George's Respiratory Questionnaire 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. 6-months post-pulmonary rehabilitation
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