Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation

NCT04700098 | Completed Results

• 1 other identifier: F3513-R
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Insomnia

Keywords

Chronic Obstructive Pulmonary Disease; Insomnia

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index (ISI)

  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.

  Baseline to 3-months post-treatment

• St. George's Respiratory Questionnaire (SGRQ)

  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.

  Baseline to 3-months post-treatment

Study Arms (2)

Internet-based behavioral treatment for insomnia

EXPERIMENTAL

Internet version of cognitive-behavioral treatment for insomnia

Behavioral: Internet-based behavioral treatment for insomnia

Online insomnia patient education

EXPERIMENTAL

Online insomnia patient education

Behavioral: Online insomnia patient education

Interventions

Internet-based behavioral treatment for insomnia BEHAVIORAL

Internet version of cognitive-behavioral treatment for insomnia

Internet-based behavioral treatment for insomnia

Online insomnia patient education BEHAVIORAL

Online insomnia patient education

Online insomnia patient education

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201-1916, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

The study did not reach the target number of participants needed to achieve target power and statistically reliable results.

Results Point of Contact

• Title: Faith Luyster
• Organization: VA Pittsburgh Healthcare System

Faith.Luyster@va.gov

412-624-7910

Study Officials

• Faith S Luyster, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Individuals will be assigned to either an internet-based behavioral treatment for insomnia or online insomnia patient education.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 7, 2021
• Study Start: February 14, 2022
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)