ISRCTN71800376进行中(未招募)Unknown
A randomised controlled trial testing the effects of treating sleep difficulties in patients at ultra-high risk of psychosis and patients diagnosed with non-affective psychosis (Sleeping Better)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 入组人数
- 1,108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 14 years or above
- •2. Patient of mental health services (at the time of referral to the trial), or for young people at UHR seeking help
- •3. Have a clinical diagnosis of schizophrenia spectrum psychosis (i.e. non-affective psychosis) (ICD-10 codes F20–29) or meet diagnostic criteria for ultra-high risk of psychosis on the Comprehensive Assessment of At-Risk-Mental-States (CAARMS)
- •4. Experiencing current sleep problems (score > 14 on the Insomnia Severity Index) and would like help to improve sleep
- •5. Willing and able to give informed consent (or assent with parent/guardian consent for participants aged 14 to 15 years) for participation in the trial
排除标准
- •1. Likely primary diagnosis of sleep apnoea (using the STOP-BANG screen [Chung et al, 2016])
- •2. A primary diagnosis of another mental health condition (e.g. substance use disorder) that would be the first clinical priority to treat
- •3. In forensic settings or Psychiatric Intensive Care Unit (PICU)
- •4. Command of spoken English inadequate for engaging in the trial
- •5. Current receipt of significant other psychological therapy or significant change in medication or in another intervention study
- •6. A participant may also not enter the trial if there is another factor (for example, current active suicidal plans that need to the focus of intervention), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures. Reason for exclusion will be recorded.
研究者
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