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临床试验/NCT02390583
NCT02390583撤回不适用

Internet Addiction and Sleep Disorders

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
number of hours each week spent gaming or online gambling

研究概览

简要总结

This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

详细描述

We will check sleep disorders among patients presenting internet dependence. Diagnosis will be followed by a specific treatment during three months. This treatment is expected to reduce prevalence of internet dependence and associated addictive disorders (alchohol, nicotine) . rate of sleep disorders is also expected to decrease under treatment.

This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

Patients will be randomised in two arms : controls (CBT treatment of Internet dependence) and intervention (CBT treatment of addiction plus CBT treatment of sleep disorders).

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
None

入排标准

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

入选标准

  • Internet addiction (Young scale ≥5)
  • Online compulsive gambling ( DSM IV scale for pathological gambling and SOGS) and/or addiction to online gaming (problem video game playing ≥ 5)
  • sleep latency >45 min/night and more than 3 nights a week
  • subjective total sleep time <6h30/night more than 3 nights a week
  • Adult patient

排除标准

  • cognitive impairments, memory disorders, non french-speaking patients
  • already known and on treatment sleep pathologies
  • somatic conditions non compatible with clinical evaluation
  • cybersex dependance
  • Treatment with dopaminergic agents
  • patients under jurisdictional assistance
  • patients non covered by the french health system
  • non consenting patients
  • History of Healthcare for internet dependence
  • Patients already treated for internet dependance
  • pregnant or lactating women
  • Patients already participating in other studies on internet dependance and sleeping disorders
  • suicide attempt before inclusion

结局指标

主要结局

number of hours each week spent gaming or online gambling

时间窗: 6 months

The evaluation period will be 7 days of follow-up visit at 6 months. Each patient will complete a connection agenda that will provide the therapist during follow-up visits.

次要结局

  • insomnia(3 and 6months)
  • number of awakenings during night(3 and 6 months)
  • Alcohol dependence(3 and 6 months)
  • Depression(3 and 6 months)
  • Number of hours spent on line gaming or online gambling(3 months)
  • total sleep time(3 and 6 months)
  • treatment with hypnotics(3 and 6 months)
  • Other psychoactive agents(3 and 6 months)
  • daytime sleepiness(3 and 6 months)
  • Anxiety(3and 6 months)
  • Nicotine Dependence(3 and 6 months)
  • Compliance(3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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