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临床试验/NCT01955928
NCT01955928已完成不适用

Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions

VU University of Amsterdam2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
2
主要终点
Daytime symptoms of sleep related worry measured with the APSQ

研究概览

简要总结

The object of this study is to compare internet-delivered treatment for insomnia to a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral 2) waiting-list. Participants in the waiting-list condition receive treatment after the post-test. The 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 will fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. In this study we are interested in sleep-related worry and daily complaints measured with a diary. We expect that the online intervention ameliorates both the sleep-related worry and the daily complaints. Furthermore, we expect that the sleep related worry mediates the effect of the intervention on sleep- and daily complaints.

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

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

排除标准

  • Earlier cognitive behavioral treatment for insomnia
  • Start other psychological treatment in the last 6 months
  • Doing shift work
  • Pregnancy or breast feeding
  • Schizophrenia or psychosis
  • Suicidal plans
  • Sleep apnea
  • drugs or alcohol abuse

研究组 & 干预措施

Online Cognitive behavioral treatment for insomnia

Experimental

Online Cognitive behavioral treatment for insomnia

干预措施: Online Cognitive behavioral treatment for insomnia (Behavioral)

Waiting-list

No Intervention

Waiting-list

结局指标

主要结局

Daytime symptoms of sleep related worry measured with the APSQ

时间窗: Change from baseline to post-test, 3-months, and 6-months follow-up

Daytime symptoms of sleep related worry will be measured with a daily Anxiety and Pre-occupation about sleep questionnaire.

Daytime symptoms measured with diary consisting of the DASS-21

时间窗: Change from baseline to post-test, 3-months, and 6-months follow-up

The daytime symptoms will be measured with the 7 items of the stress scale of the DASS-21

次要结局

  • Depression measured with the CES-D(Change from baseline to post-test, 3-months, and 6-months follow-up)
  • Anxiety measured with the HADS-A(Change from baseline to post-test, 3-months, and 6-months follow-up)
  • Sleep related safety behaviors measured with the SRBQ(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)
  • 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)
  • Repetitive thinking measured with the Dutch Perseverative Thinking Questionnaire(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)
  • sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)(Change from baseline to post-test, 3-months, and 6-months follow-up)

研究者

发起方
VU University of Amsterdam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaap Lancee

PhD

University of Amsterdam

研究点 (2)

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