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
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