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临床试验/CTRI/2017/06/008753
CTRI/2017/06/008753已完成未知

Cognitive Behavioral Therapy Sleep quality improvement

nil0 个研究点目标入组 48 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
48

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • (1) Subjects who meet diagnostic criteria for PI and effectively screened through structured psychiatric and sleep interviews (Williams et al., 1992; First et al., 1996)
  • (2) Subjects who have no notable physiological illnesses affecting sleep
  • (3)Subjects who have a mean WASO(Wake after sleep onset) and/or SOL(Sleep Onset Latency) >30 minutes in a week of sleep log monitoring
  • (4) Subjects who have complaints of daytime fatigue and sleepiness
  • (5) Subjects who have Insomnia Severity Index >15
  • (6) Subjects with sleep disturbance of at least 3 nights per week for at least 6 months
  • Williams, J. B., Gibbon, M., First, M. B. et al. The structured clinical interview for DSM-III-R (SCID): II. Multisite test-retest reliability. Arch. Gen. Psychiatry, 1992, 49: 630-636.
  • First, M., Spitzer, R., Williams, J., & Gibbon, M. Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). New York: Biomedics Research Department, New York State Psychiatric Institute, 1996.
  • Edinger, J. D., Bonnet, M. H., Bootzin, R. R. et al. Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group. Sleep, 2004, 27:1567-1596.

排除标准

  • (1) Reported alcohol or drug abuse or unstable current medication in the past year, non-clinically noteworthy insomnia (Edinger et al., 2004)
  • (2) Could not commit for enough time to participate in the study or disagree to take part
  • (3) Subjects with Total Sleep Time (TST (Total Sleep time) > 6 hrs), Sleep efficiency (SE > 85%), WASO >60 mins in a week of sleep log monitoring, ISI (Insomnia severity index) >22, and a sustained stable sleep period between 22:00 and 08:00 hrs

研究者

发起方
nil

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