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临床试验/NCT04308499
NCT04308499终止不适用

Pilot Randomized Controlled Trial of Digital Cognitive-Behavioral Therapy for Insomnia in HIV-Infected Individuals

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
2
主要终点
Change in Sleep Efficiency

研究概览

简要总结

Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • DSM-5 diagnosis of insomnia disorder
  • Aged 18 years or older
  • Reliable Internet access using either computer or smartphone
  • Ability to read and understand English

排除标准

  • High risk of obstructive sleep apnea
  • Diagnosis of restless legs syndrome
  • Severe health issues requiring hospital admission
  • Currently receiving psychological treatment for insomnia
  • Reporting current suicidal ideation

结局指标

主要结局

Change in Sleep Efficiency

时间窗: Weeks 0, 4, 8, and 24

Change in sleep efficiency estimated using sleep diary with higher percentages indicating better outcome (range 0-100%)

Change in Insomnia Severity Index (ISI)

时间窗: Weeks 0, 4, 8, and 24

Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)

次要结局

  • Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)(Weeks 0, 4, 8, and 24)
  • Change in Total Sleep Time (TST)(Weeks 0, 4, 8, and 24)
  • Change in Center for Epidemiologic Studies Depression Scale (CES-D)(Weeks 0, 4, 8, and 24)
  • Change in Snaith-Hamilton Pleasure Scale (SHAPS)(Weeks 0, 4, 8, and 24)
  • Change in Generalized Anxiety Disorder 7-item scale (GAD-7)(Weeks 0, 4, 8, and 24)
  • Change in Insomnia Caseness(Weeks 0, 4, 8, and 24)
  • Change in UCLA Loneliness Scale (ULS)(Weeks 0, 4, 8, and 24)
  • Change in Epworth Sleepiness Scale (ESS)(Weeks 0, 4, 8, and 24)

研究者

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

Joshua Hyong-Jin Cho

Associate professor

University of California, Los Angeles

研究点 (2)

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