Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
研究概览
简要总结
The object of this study is to compare internet-delivered treatment for insomnia to face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Both the online and face-to-face interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. Participants on the waiting-list receive online treatment after the first post-test. The investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.
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 disorder according to DSM-5
- •Sleep onset latency/wake after sleep onset > 30 minutes , three times or more a week
- •Insomnia three months or longer
- •Access to internet
- •Possibility to travel to one of the treatment sites
排除标准
- •Earlier cognitive behavioral treatment for insomnia
- •Start other psychological treatment in the last 6 months
- •Doing shift work
- •Major depression disorder
- •Pregnancy or breast feeding
- •Schizophrenia or psychosis
- •Suicidal plans
- •Sleep apnea
- •drugs or alcohol abuse
结局指标
主要结局
Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
时间窗: Change from baseline to post-test, 3-months, and 6-months follow-up
For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.
Insomnia Severity Index
时间窗: Change from baseline to post-test, 3-months, and 6-months follow-up
次要结局
- Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale(Change from baseline to post-test, 3-months, and 6-months follow-up)
- Anxiety (HADS-A)(Change from baseline to post-test, 3-months, and 6-months follow-up)
- Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)(Change from baseline to post-test, 3-months, and 6-months follow-up)
- Sleep medication usage per day measured with the sleep diary(Change from baseline to post-test, 3-months, and 6-months follow-up)
- Depression measured with the CES-D(Change from baseline to post-test, 3-months, and 6-months follow-up)
- Sleep related arousal measured with the Pre-arousal sleep scale(Change from baseline to post-test, 3-months, and 6-months follow-up)
研究者
Jaap Lancee
PhD
VU University of Amsterdam