Chronic Obstructive Pulmonary Disease, Insomnia
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Insomnia
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.
Detailed 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.
Interventions
BEHAVIORALInternet-based behavioral treatment for insomnia
Internet version of cognitive-behavioral treatment for insomnia
BEHAVIORALOnline insomnia patient education
Online insomnia patient education
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be blinded to group assignment.
Intervention model description
Individuals will be assigned to either an internet-based behavioral treatment for insomnia or online insomnia patient education.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Baseline to 3-months post-treatment | 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. |
| St. George's Respiratory Questionnaire (SGRQ) | Baseline to 3-months post-treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFaith S Luyster, PhD
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Insomnia Severity Index | 15.5 score on a scale STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
| St. George's Respiratory Questionnaire | 49.6 score on a scale STANDARD_DEVIATION 16.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 5 |
| other Total, other adverse events | 1 / 8 | 0 / 5 |
| serious Total, serious adverse events | 0 / 8 | 1 / 5 |
Outcome results
None listed