Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
Primary Purpose
Chronic Obstructive Pulmonary Disease, Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based behavioral treatment for insomnia + HBPR
HBPR only
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Insomnia
Eligibility Criteria
Inclusion Criteria:
- Age 40 years and older
- Primary diagnosis of COPD defined by GOLD
- Meets criteria for enrollment in pulmonary rehabilitation
- Meets criteria for Insomnia Disorder
- At least moderate insomnia severity based on Insomnia Severity Index score 10
- Stable psychiatric and medical conditions
- Must have telephone, email, and reliable Internet access via computer, smartphone, or tablet
Exclusion Criteria:
- Enrolled in pulmonary rehabilitation in the past 12 months
- 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 9 months
- Non-English speaking or sensory deficits
Sites / Locations
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Internet-based behavioral treatment for insomnia + HBPR
HBPR only
Arm Description
Internet version of cognitive-behavioral treatment for insomnia plus home-based pulmonary rehabilitation
Home-based pulmonary rehabilitation only
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04700098
First Posted
January 4, 2021
Last Updated
February 7, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04700098
Brief Title
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
Official Title
Enhancing Pulmonary Rehabilitation in Veterans With Chronic Obstructive Pulmonary Disease Through Internet-based Cognitive-behavioral Treatment for Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
September 2, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 during home-based pulmonary rehabilitation (HBPR) versus those only receiving HBPR. Participants will undergo a sleep and health assessment that will be performed prior to the beginning of HBPR and at the end of HBPR and 6-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia plus HBPR or HBPR only.
Detailed Description
Veterans with chronic obstructive pulmonary disease (COPD) are a vulnerable group for developing insomnia. Pulmonary rehabilitation is a key component of COPD management, yet it does not address sleep. Comorbid insomnia may interfere with Veterans achieving maximum benefits from pulmonary rehabilitation. Implementing an insomnia-specific treatment in Veterans with COPD undergoing pulmonary rehabilitation will likely lead to improved sleep that could help improve and sustain the benefits gained from pulmonary rehabilitation.
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 during home-based pulmonary rehabilitation (HBPR) versus those only receiving HBPR. 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 prior to the beginning of HBPR and at the end of HBPR and 6-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia plus HBPR or HBPR only. Both the insomnia treatment and HBPR will be provided remotely.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Insomnia
Keywords
Chronic Obstructive Pulmonary Disease, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals will be assigned to either an internet-based behavioral treatment for insomnia plus home-based pulmonary rehabilitation or home-based pulmonary rehabilitation only simultaneously.
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be blinded to group assignment.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-based behavioral treatment for insomnia + HBPR
Arm Type
Experimental
Arm Description
Internet version of cognitive-behavioral treatment for insomnia plus home-based pulmonary rehabilitation
Arm Title
HBPR only
Arm Type
Experimental
Arm Description
Home-based pulmonary rehabilitation only
Intervention Type
Behavioral
Intervention Name(s)
Internet-based behavioral treatment for insomnia + HBPR
Intervention Description
Internet version of cognitive-behavioral treatment for insomnia plus home-based pulmonary rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
HBPR only
Intervention Description
Home-based pulmonary rehabilitation only
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
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.
Time Frame
Baseline to post-pulmonary rehabilitation and 6-months post-pulmonary rehabilitation
Title
St. George's Respiratory Questionnaire
Description
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.
Time Frame
6-months post-pulmonary rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 40 years and older
Primary diagnosis of COPD defined by GOLD
Meets criteria for enrollment in pulmonary rehabilitation
Meets criteria for Insomnia Disorder
At least moderate insomnia severity based on Insomnia Severity Index score 10
Stable psychiatric and medical conditions
Must have telephone, email, and reliable Internet access via computer, smartphone, or tablet
Exclusion Criteria:
Enrolled in pulmonary rehabilitation in the past 12 months
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 9 months
Non-English speaking or sensory deficits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faith S Luyster, PhD
Phone
(412) 360-2854
Email
Faith.Luyster@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith S Luyster, PhD
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faith S Luyster, PhD
Phone
412-360-2854
Email
Faith.Luyster@va.gov
First Name & Middle Initial & Last Name & Degree
Faith S Luyster, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
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