Treatment of Insomnia in Primary Care Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Mean Change from Baseline in Insomnia Severity Index (ISI) score at 8 weeks
研究概览
简要总结
The goal of this clinical trial is to learn about insomnia treatment among primary care patients with chronic insomnia.
The main question it aims to answer is:
• Does Sleep School (a therapy for insomnia) work well to decrease harm of insomnia? Participants will attend a group therapy intervention once a week for six weeks.
Researchers will compare Sleep School to treatment as usual (short counselling by an educated nurse) to see if the Sleep School works better than treatment as usual in decreasing the harm of insomnia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insomnia severity index (ISI) score at least 8
- •insomnia symptoms present at least for 3 months
排除标准
- •diagnosed dementia based on medical records
- •acute suicidality
- •acute psychotic symptoms
结局指标
主要结局
Mean Change from Baseline in Insomnia Severity Index (ISI) score at 8 weeks
时间窗: Baseline and Week 8
The ISI is a validated self-report tool for assessing the severity, and impact of current insomnia symptoms. It consists of 7 Likert-scale questions with a total score ranging from 0 to 28 (with higher scores indicating more severe insomnia). Change = Week 8 score - Baseline score.
次要结局
- Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 8 weeks(Baseline and Week 8)
- Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 8 weeks(Baseline and Week 8)
- Mean change from Baseline in Work Ability Score (WAS) at 8 weeks(Baseline and Week 8)
研究者
Päivi Korhonen
Professor of General Practice
University of Turku