Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Remission of insomnia
研究概览
简要总结
The primary objective of this pragmatic clinical trial is to evaluate the efficacy, feasibility, and adaptability of pharmacological and non-pharmacological treatments for insomnia disorder, delivered in primary care clinics. The second objective is to evaluate the efficacy of a sequential (stepped care) approach for persistent insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Aged 18 years or over
- •Meeting criteria for insomnia disorder
- •Registered patient at one of the primary care clinics participating in the study
- •Fluent in French
- •Computer and internet access
排除标准
- •Unstable or untreated psychiatric disorder
- •Lifetime psychotic or bipolar disorder
- •Current suicide risk
- •Progressive or unstable medical disorder
- •Untreated sleep disorder other than insomnia
- •Use of medication altering sleep
- •Irregular or atypical sleep-wake schedule
- •Current or planned pregnancy
研究组 & 干预措施
Treatment as usual
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks
干预措施: Hypnotics (Drug)
Online cognitive behavior therapy
Online CBT- Internet self-help program for insomnia with 6 cores
干预措施: Online CBT (Behavioral)
Treatment as usual + Online CBT
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores
干预措施: Hypnotics (Drug)
Treatment as usual + Online CBT
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores
干预措施: Online CBT (Behavioral)
Medication
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)
干预措施: Hypnotics (Drug)
In-person cognitive behavior therapy
Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
干预措施: Face-to-face CBT (Behavioral)
结局指标
主要结局
Remission of insomnia
时间窗: Post-2 (after 6-week treatment phase 2)
Insomnia Severity Index score (average of two consecutive weeks \< 8, with none \> 10)
次要结局
- Total sleep time from sleep diary(Post-2 (after 6-week treatment phase 2))
- Sleep efficiency from actigraphy(Post-2 (after 6-week treatment phase 2))
- Depression(Post-2 (after 6-week treatment phase 2))
- Anxiety(Post-2 (after 6-week treatment phase 2))
- Disability(Post-2 (after 6-week treatment phase 2))
- Medication use(Post-2 (after 6-week treatment phase 2))
- Total wake time from sleep diary(Post-2 (after 6-week treatment phase 2))
- Sleep efficiency from sleep diary(Post-2 (after 6-week treatment phase 2))
- Total sleep time from actigraphy(Post-2 (after 6-week treatment phase 2))
- Total wake time from actigraphy(Post-2 (after 6-week treatment phase 2))
- Fatigue(Post-2 (after 6-week treatment phase 2))
研究者
Charles M. Morin
Professor
Laval University