Group Treatment for Insomnia in Primary Health Care: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 4
- 主要终点
- Insomnia severity Index
研究概览
简要总结
The aim of this study is to analyze if group treatment is effective to treat insomnia in primary healthcare.
详细描述
Insomnia is a common health problem. Untreated insomnia may lead to decreased physical and mental health. The patients turns to Primary Health Care when daytime symptoms decrease social and occupational function. Previous studies have shown that cognitive and behavioral therapy have effects on insomnia and recommends as first line treatment but is not widely available in primary health care.
The purpose is to test the effect of group intervention in Primary Health Care for patients with insomnia. The outcomes is insomnia severity, sleep habits, use of hypnotics, Fatigue, general health and health related quality of life. Characters with insomnia visiting in Primary Health Care.
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 symptoms regarding DSM-V
- •Motivated to group treatment.
排除标准
- •Insomnia Severity Index less than 7 points
- •Presence of acute life crises, acute psychiatric illness, bipolar disorder
- •Shift work
- •Linguistic or cognitive difficulties causing inability participate in group or fill in forms
- •Insomnia directly caused by medical illness. Other sleep disorder.
研究组 & 干预措施
Group treatment for insomnia
Group treatment for insomnia.
干预措施: Group treatment for insomnia (Behavioral)
No intervention
Treatment as usual
结局指标
主要结局
Insomnia severity Index
时间窗: One year
Insomnia Severity Index (ISI)is a seven item self assessment scale measuring severity of insomnia symptoms during the last two weeks. The items asks about sleep disturbance, daytime functioning and worrying about sleep. The possibly response is 0 "None" 1 "Mild" 2 "Moderate" 3 "Severe" 4 "Very severe". The sum is added and 0-7 p grades the insomnia to "none clinically significant insomnia", 8-14 p "subtreshold insomnia", 15-21 p "moderate insomnia", 22-28 p "severe insomnia".
次要结局
- Fatigue severity scale(one year)
研究者
Jeanette Westman
PhD
Karolinska Institutet