ISRCTN42499563已完成未知
A pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy (SRT) for insomnia disorder to sleep hygiene (SH) in primary care
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 642
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32139496/ protocol (added 15/02/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37573859/ (added 14/08/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39185919/ (added 27/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 19/02/2020:
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM-5 (American Psychiatric Association) on structured checklist review
- •3. Sleep efficiency < 85% over the past month
- •4. Age =18 years
- •5. Able to attend appointments during baseline and 4-week intervention (both face-to-face at the practice and over the phone) and adhere to study procedures
- •6. Registered at a GP practice taking part in the trial
- •Previous participant inclusion criteria:
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM-5 (American Psychiatric Association) on structured checklist review
- •3. Sleep efficiency < 85% over the past month
- •4. Age =18 years
- •5. Able to attend appointments during baseline and 4-week intervention (both face-to-face at the practice and over the phone) and adhere to study procedures
排除标准
- •Current participant exclusion criteria as of 19/02/2020:
- •1. Pregnant/pregnancy planning in the next 6 months
- •2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
- •3. Dementia/ Mild Cognitive Impairment (MCI)
- •4. Epilepsy
- •5. Psychosis (schizophrenia, bipolar disorder)
- •6. Current suicidal ideation with intent OR attempted suicide within past 2 months
- •7. Currently receiving cancer treatment OR planned major surgery during treatment phase
- •8. Night, evening, early morning or rotating shift-work
- •9. Currently receiving psychological treatment for insomnia from a health professional
- •10. Life expectancy of <2 years
- •11. Another person in the same household participates in this trial
- •Previous exclusion criteria as of 17/09/2019:
- •1. Pregnant/pregnancy planning in the next 6 months
- •2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
- •3. Dementia/ Mild Cognitive Impairment (MCI)
- •4. Epilepsy
- •5. Psychosis (schizophrenia, bipolar disorder)
- •6. Current suicidal ideation with intent OR attempted suicide within past 2 months
- •7. Currently receiving cancer treatment OR planned major surgery during treatment phase
- •8. Night, evening, early morning or rotating shift-work
- •9. Currently receiving psychological treatment for insomnia from a health professional
- •10. Life expectancy of < 2 years
- •Previous exclusion criteria as of 21/08/2018:
- •1. Pregnant/pregnancy planning in the next 6 months
- •2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
- •3. Dementia
- •4. Epilepsy
- •5. Psychosis (schizophrenia, bipolar disorder)
- •6. Current suicidal ideation with intent OR attempted suicide within past 2 months
- •7. Currently receiving cancer treatment OR planned major surgery during treatment phase
- •8. Night, evening, early morning or rotating shift-work
- •9. Currently receiving psychological treatment for insomnia from a health professional or taking part in an online treatment programme for insomnia.
- •10. Life expectancy of <2 years
- •Previous exclusion criteria:
- •1. Pregnant/pregnancy planning in the next 6 months
- •2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
- •3. Dementia
- •4. Epilepsy
- •5. Psychosis (schizophrenia, bipolar disorder)
- •6. Current suicidal ideation with intent OR attempted suicide within past 2 months
- •7. Currently receiving cancer treatment OR planned major surgery during treatment phase
- •8. Night, evening, early morning or rotating shift-work
- •9. Trans-meridian travel planned during the baseline assessments or for > 3 nights during treatment phase
- •10. Currently receiving psychological treatment for insomnia from a health professional
- •11. Life expectancy of < 2 years
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