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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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Insomnia is a major problem among veteran populations. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized Intervention 1 | Experimental | A web-based program will deliver components of CBT-I on a time and event-based schedule. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention. |
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| Computerized Intervention 2 | Active Comparator | A web-based program will deliver components of sleep education via an Internet platform. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Cognitive Behavioral Therapy for Insomnia | Behavioral | A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Symptom Severity; Time 1 to Time 2 | The primary analysis will be the intent-to-treat comparison between groups of the change in insomnia symptom severity as measured by the Insomnia Severity Index (ISI) from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check. | Baseline and 9 weeks |
| Change in Mental Health; Time 1 to Time 2 | The primary analysis will be the intent-to-treat comparison between groups of the change in Mental Health summary score, as measured by the Veteran's SF-36, from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check. | Baseline and 9 weeks |
| Change in Physical Health ; Time 1 to Time 2 | The primary analysis will be the intent-to-treat comparison between groups of the change in Physical Health summary score, as measured by the Veteran's SF-36, from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve the precision of the estimate, and any potential confounders discovered in the randomization check. | Baseline and 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarra Nazem, PhD | VHAECH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA | Aurora | Colorado | 80045 | United States |
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| Sleep Education | Behavioral | A web-based program will deliver components of sleep education via an Internet platform |
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| Change in Insomnia Symptom Severity; Time 1 to Time 3 | A similar analysis will be performed for the above noted insomnia symptom severity outcome on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention. | Baseline and 6 Months |
| Change in Mental Health; Time 1 to Time 3 | A similar analysis will be performed for the above noted Mental Health summary score, as measured by the Veteran's SF-36, on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention. | Baseline and 6 Months |
| Change in Physical Health; Time 1 to Time 3 | A similar analysis will be performed for the above noted Physical Health summary score, as measured by the Veteran's SF-36, on the change from Time 1 to Time 3 to determine persistence of group differences to six-months post-intervention. | Baseline and 6 Months |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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