Computerized Self-Help Treatment for Primary Insomnia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in sleep parameters via polysomnography
研究概览
简要总结
The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.
详细描述
Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. Most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. Therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population.
Comparison: We are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sleep less than 6.5 hours per night
- •at least 30 minutes of sleep onset latency or wakefulness after sleep onset
- •symptoms present for at least 6 months
- •must have insomnia symptoms at least 3 days per week
排除标准
- •Body Mass Index greater than 32
- •Presence of anxiety disorder
- •Secondary forms of insomnia
- •Presence of a substance use disorder
- •Concurrent treatment for another mental disorder
- •History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy
结局指标
主要结局
Changes in sleep parameters via polysomnography
Changes in sleep parameters via self-reported sleep diary
Changes in symptom severity as measured by Insomnia Severity Index
Changes in symptom severity as measured by Pittsburgh Sleep Quality Index
Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory
次要结局
- Changes in depression symptoms as measured by Beck Depression Inventory II
- Changes in quality of life as measured by a qualitative instrument
- Usability of the device as measured by a qualitative questionnaire