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临床试验/ACTRN12623000892617
ACTRN12623000892617招募中Unknown

Feasibility of at-home virtual reality delivered mindfulness for insomnia and related symptoms in a community sample with self-reported chronic insomnia.

niversity of Newcastle0 个研究点目标入组 43 人开始时间: 2023年8月21日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
43

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 80 Years(—)
性别
All

入选标准

  • 1. Aged 18 - 80 years.
  • 2. Proficient in reading, writing, and communicating in English.
  • 3. Insomnia symptoms (difficulty falling asleep, staying asleep, or waking too early) at least 3 times per week for a minimum of 3 months and an Insomnia Severity Index (ISI) score greater than or equal to 10.
  • 4. Able to attend an in-person baseline appointment.
  • 5. Be willing to be randomised to VR or 2D (computer) delivered mindfulness.
  • 6. Willing to use a VR headset to complete the twice weekly VR-delivered mindfulness sessions if randomised to the VR condition.

排除标准

  • 1. Unable to move the head in all directions and wear a VR head-mounted display
  • 2. Vertigo or related conditions (e.g., Meniere's disease)
  • 3. Unstable medication regimen, defined as having commenced, discontinued, or changed medication or its dosage within < 2 weeks
  • 4. Substance use at a level or of a type likely to cause significant impairment, defined as a high score on the Alcohol Use Disorders Identification Test (AUDIT-C).
  • 5. Admission to a psychiatric hospital within the last 12 months
  • 6. Diagnosed severe psychiatric illness (e.g., Schizophrenia)
  • 7. Thoughts of self-harm in the last 2 weeks, defined as Patient Health Questionnaire (PHQ -9) score >1 on question 9
  • 8. Sleep disorder (other than insomnia) due to neurological or medical cause (e.g., parasomnias, OSA, narcolepsy, seizure) or prescribed sleep aid (e.g., CPAP)

研究者

发起方
niversity of Newcastle

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