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临床试验/NCT02612987
NCT02612987已完成不适用

Internet-delivered Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia Attending Children and Youth Psychiatry: An Open Trial

Uppsala University Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Insomnia Severity Index (ISI; Morin, 1993)

研究概览

简要总结

Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Treatment of insomnia has been extensively examined in adults, but studies with adolescents are sparse. The purpose of this pilot study is to assess the feasibility and efficacy of internet-based cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children and Youth Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT. Outcome will be measured at pre treatment, at post treatment and at a three months follow-up. Weekly assessments will also be made during treatment on primary outcome and a presumed process variable constructed for the purpose of this trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • To fulfill the diagnostic criteria for insomnia
  • To have access to a computer with Internet connection
  • No previous or ongoing CBT for insomnia
  • No psychotropic medication or being on a stable dosage for at least six weeks before enrollment

排除标准

  • Ongoing manic or psychotic episode
  • Being at high risk of triggering manic or psychotic episode
  • Ongoing sleep apnea

结局指标

主要结局

Insomnia Severity Index (ISI; Morin, 1993)

时间窗: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up

Given that this is an intervention study we are assessing changes in outcome over time.

次要结局

  • Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)(Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up)
  • The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012)(Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up)
  • Symptoms Checklist (SCL-90; Derogatis et al., 1994)(Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vendela Zetterqvist

Ph D, licensed psychologist

Uppsala University Hospital

研究点 (2)

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