跳至主要内容
临床试验/NCT02571595
NCT02571595终止不适用

Efficacy Potential of an Internet-based Sleep Program to Improve Sleep Quality in People With HIV

McGill University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
2
主要终点
Ratio of total sleep time over time in bed

研究概览

简要总结

Sleep problems, such as insomnia, are more frequent and intense in individuals living with HIV. These sleep difficulties can increase the difficulties in thinking and concentrating. Digital cognitive behavioral therapy for insomnia (dCBT-I) is a computer-based treatment intervention that provides strategies to improve sleep. This intervention has been shown to improve sleep and daytime function (concentration, productivity) in people with insomnia. However, the effects of this intervention in people living with HIV are unknown.

详细描述

Sleep disturbances have been consistently reported in HIV+ individuals, and occur early in the course of infection. Among disorders of sleep commonly found in HIV, insomnia is by far the most frequent condition, affecting almost 75% of HIV-infected individuals. Compared to non-infected individuals, HIV+ patients are 17% more likely to develop insomnia. Furthermore, not only is insomnia more frequent in HIV; it is also more severe in HIV+ compared to HIV- individuals. The precise mechanisms underlying the vulnerability of this population to insomnia still remain hypothetical, and might involve neurodegenerative processes related to the infection, associated mood disorders (e.g., depression, anxiety), side effects of antiretroviral medications, and psychosocial factors. Importantly, sleep disorders in HIV have been demonstrated to affect the severity of the infection. For instance, sleep disturbances were shown to mediate the association between psychological distress and immune status (T-cytotoxic/suppressor cell counts). In addition, sleep disruption also affects responses to treatment, as illustrated by a report demonstrating that sleep disturbances mediate the association between medication adherence and self-reported HIV symptom severity. Finally, insomnia in HIV seems to be closely associated with the presence of cognitive disturbances. Indeed, virtually all HIV infected individuals with cognitive impairment present insomnia complaints, and greater sleep disturbances were associated with worse cognitive performance (e.g., executive functions, psychomotor speed) in this population. Therefore, insomnia has been shown to affect symptom severity, treatment adherence and cognition in HIV+ individuals.

Despite this demonstrated importance of sleep for the well-being of HIV patients, there are very few studies of sleep treatment interventions in HIV. Two studies have implemented an educational intervention promoting healthy sleep habits (e.g., healthy diet, reduced caffeine consumption, no exercise before bedtime, regular sleep-wake schedules), consisting of either one single session or 10 weekly sessions, with little or no consistent sleep improvement in this population. This is not surprising given that previous studies showed the very limited efficacy of interventions focusing solely on sleep hygiene in a general chronic insomnia population.

The most effective treatment for chronic insomnia currently consists of a multimodal psychological intervention, called cognitive-behavioral therapy for insomnia (CBT-I). CBT-I improves sleep to the same degree as hypnotic medications in the short term, but, in contrast to hypnotics, shows no side effects and remains effective in the long term, with sustained improvement in sleep and daytime functioning up to 2 years after completion of the therapy. CBT-I has proven effective in patients with primary insomnia (i.e. without associated medical condition), as well as in insomnia comorbid with depression or cancer. However, the efficacy of CBT-I has not been studied in HIV+ individuals with insomnia.

Digital Cognitive-Behavioural Therapy for Insomnia (CBT-I): the Sleepio program

CBT-I is an intervention aimed at breaking the patterns of maladaptive thinking and behavior that serve to maintain insomnia. It includes a range of techniques including a behavioral component (stimulus control, sleep restriction, relaxation) combined with a cognitive (managing sleep related worries, the racing mind and intrusive thoughts) and an educational (sleep hygiene) component. CBT-I is usually dispensed in group sessions, including 5 to 8 patients and a trained therapist. The different components of CBT-I are then covered in 6 to 8 weekly sessions of 60-90 minutes each. While CBT-I has been demonstrated as an efficacious treatment option, the personnel-intensive nature of CBT-I constitutes an important barrier to widespread clinical use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

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

入选标准

  • Evidence of insomnia disorder (Sleep Condition Indicator [SCI] ≤ 16)
  • Able to have convenient weekly access to the Internet
  • Stable medical condition
  • Have been on a stable HAART regimen for > 6 months
  • Have not had a change in medications that could potentially interfere with sleep or cognition in the past 4 months.

排除标准

  • Berlin questionnaire score indicating high risk of obstructive sleep apnea
  • Known history of sleep disorders (e.g., narcolepsy, hypersomnia, restless legs syndrome, REM-sleep behavior disorder) which currently require or previously required treatment
  • Ongoing involvement in night shift work
  • Not able to complete the 12 weeks of the sleep intervention due to a scheduling conflict

结局指标

主要结局

Ratio of total sleep time over time in bed

时间窗: 12 weeks

Obtained from the online self-reported sleep diaries aggregated over 7 days, completed at study entry and again at 12 weeks

次要结局

  • Insomnia Severity as assessed by the Insomnia Severity Index(12 weeks)
  • Cognitive performance as assessed by the Brief Cognitive Ability Measure (B-CAM)(9 months)
  • Anxiety and Depression symptoms as assessed by the Hospital Anxiety Depression Scale(9 months)
  • Quality of life as assessed by the WHO-QOL-HIV(9 months)
  • Quality of life as assessed by the EQ-5D(9 months)

研究者

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

Lesley K. Fellows

Neurologist

McGill University

研究点 (2)

Loading locations...

相似试验