Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index
研究概览
简要总结
Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. 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) and Department of Defense (DoD). 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 55
- •History of deployment in the Global War on Terror
- •Eligible to receive care through VA ECHCS
- •Reliable access to the Internet
- •English speaking
- •Able to provide informed consent
- •Current insomnia diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) criteria
排除标准
- •Currently enrolled in/participating in other intervention research studies
- •Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)
- •Currently receiving formal psychological treatment for insomnia (not including sleep medications)
- •Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep
- •History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder
- •Untreated seizures or seizure disorder
- •Physical illness that is active, unstable, degenerative, and/or progressive
- •Currently pregnant or plan to become pregnant in the next 6 months
- •Irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns
- •Significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in SHUTi
- •Current non-alcohol Substance Use Disorder, excluding Cannabis Use Disorder, as determined by chart review and/or self-report screen of drug use (> 1 time) in past 3 months
- •Current Alcohol Use Diagnosis, as determined by SCID 5 module, in the past 3 months
结局指标
主要结局
Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index
时间窗: Baseline and 9 Weeks
The primary analyses will be the intent-to-treat comparison between groups of the change in insomnia symptom severity as measured by the 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 precision of the estimate, and any potential confounders discovered in the randomization check.
Maintenance of Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index at 6-months and 1-Year Post-Intervention
时间窗: Baseline, 6-Months and 1-Year
A similar analysis will be performed for the above noted insomnia severity outcome on the change from Time 1 to Time 3 and to Time 4 to determine persistence of group differences to six-months and one-year post-intervention.
次要结局
- Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36(Baseline and 9 Weeks)
- Maintenance of Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36 at 6-months and 1-Year Post-Intervention(Baseline, 6-Months and 1-Year)