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临床试验/ACTRN12615000751572
ACTRN12615000751572已完成未知

Can objective measures of phenotypes of Insomnia Disorder built on either polysomnographic sleep or dim light melatonin onset predict treatment response (insomnia severity index scores, sleep onset latency & wake-time after sleep onset) to cognitive behavioural therapy compared to classic insomnia clinical phenotypes?

Woolcock Institute of Medical Research0 个研究点目标入组 325 人开始时间: 2015年7月21日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
325

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1. Symptoms of Insomnia Disorder as diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for insomnia disorder (APA, 2013) specifically: Difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty.
  • 2. Insomnia Severity Index score more than or equal to 10
  • 3. Fluent speaker of English
  • 4. Aged >18 years
  • 5. Stable sleep/wake schedule (habitual bedtime 22:00-00:00 +/- 2 hours)
  • 6. Able to give informed, written consent

排除标准

  • 1. Pregnancy or lactation
  • 2. Active illicit substance use or alcohol/caffeine dependence
  • 3. Medications that interfere with sleep (within 1 month of assessment)
  • 4. Psychiatric disorders, other than mild to moderate depression (on the
  • Depression Anxiety Stress Scales)
  • 5. Another sleep disorder evaluated by a Sleep Physician / Sleep Psychologist that better explains the complaint of sleep loss.
  • 6. Severe cognitive impairment that does not allow patients to consent or follow study instructions
  • 7. Overnight shift workers and recent time-zone travel (within last 2 months)
  • 8. Actively treated sleep disorder (e.g. CPAP/CBT-I)

研究者

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